BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2873366 · Received December 14, 2012

    Report

    Report Number
    3008382007-2012-08202
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 17, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT THAT HER ONETOUCH ULTRA2 METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE STARTED AT AN UNSPECIFIED TIME ON (B)(6) 2012. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH A COMBINATION OF ORAL MEDICATION AND INSULIN. THE PATIENT DENIED TAKING ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED POWER ISSUE. FOUR HOURS AFTER THE POWER ISSUE WAS DISCOVERED THE PATIENT STATED SHE DEVELOPED SYMPTOMS OF "VOMITING, NAUSEOUS, DIZZINESS, RACING HEART AND TINGLING IN THE FEET '. THE PATIENT STATED, SHE WAS TAKEN TO THE ER WHERE HER BLOOD GLUCOSE TESTED AT 500 MG/DL WITH AN ER/HOSPITAL METER. THE PATIENT STATED SHE WAS TREATED WITH INSULIN AND ORAL MEDICATION. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS MISUSE TO THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND THE PATIENT WAS ASKED TO RETURN THE SUBJECT METER. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER POWER ISSUE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3354646

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R