CARDIOLOGY AND VASCULAR

Alert on faulty diabetes tests

Source: IrishHealth.com

August 16, 2013

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  • People with diabetes have potentially been overestimating the amount of insulin they need as a result of thousands of faulty blood glucose testing strips coming onto the Irish market.

    The Irish Medicines Board (IMB) has confirmed to irishhealth.com that 4,100 boxes of GlucoMen LX Sensor testing strips have been subject to a manufacturing fault and some of the strips could potentially give an overestimation of blood glucose levels in diabetes patients.

    Some of the test strips from the affected lot number 3212214249 'may give an overestimation of blood glucose levels, potentially resulting in inappropriate insulin administration,' the IMB said.

    It has advised that any patient who may have these strips not to use them but to return them to their pharmacy.

    However, the Medicines Board stressed that the manufacturers and Irish distributors believe it is unlikely that test strips from the affected lot remain in circulation. It stressed too, that no adverse incident reports in relation to the use of these test strips had come to light.

    Medicon Ireland Ltd, the distributors of the strips, is currently notifying customers and asking them to return any product still held by then for replacmeent. The strips and the glucose meters used with them are normally available through pharmacies to diabetes patients.

    The strips are manufactured by the Italian-based multinational A. Menarini Diagnostics.

    An alert about the faulty test strips was issued in the UK on Wednesday by the medical devices safety watchdog, the MHRA.

    The MHRA said there were two potentially faulty lots of strips distributed in the UK, but they have not been sold in there since November 2012. It has not been clarified at this stage exactly when the faulty strips would have been circulating in Ireland.

    According to the alert issued in the UK, the manufacturing fault has now been resolved and there is currently no evidence that UK patients had been adversely affected by the faulty test strips.

    This is the second alert issued in Ireland over the past three days on a medical desting device error.

    On Wednesday, it was revealed that a mislabelling of 540 blood test kits may have potentially led to newborn babies been assigned the wrong blood group.

    As a result of the error, there was also a risk that some of the mothers and babies may potentially have been given treatments they did not need or else did not receive treatments they needed as a result of the mislabelling.

    However, the HSE said there were no immediate safety concerns about the blood test mislabelling and the chances of babies being assigned a wrong blood group were extremely low.

    Blood kit errors known back in June

    © Medmedia Publications/IrishHealth.com 2013