BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2920372 · Received January 17, 2013

    Report

    Report Number
    3008382007-2013-01059
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRAMINI METER WOULD NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE PATIENT BY PHONE. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE STARTED ON (B)(6) 2013 AT 8:30 (AM/PM NOT SPECIFIED). THE PATIENT INFORMED THE CCA THAT HE MANAGES HIS DIABETES WITH INSULIN. IT IS NOT KNOWN WHAT ACTION, IF ANY, THE PATIENT TOOK REGARDING HIS DIABETES MANAGEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE PATIENT REPORTED FEELING SWEATY AND DIZZY APPROXIMATELY 5 MINUTES AFTER THE ISSUE STARTED AND REPORTED GOING TO THE ER AT 8:45PM. IT IS NOT KNOWN IF THE PATIENT RECEIVED ANY MEDICAL TREATMENT AT THE TIME OF THE ER VISIT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THERE WAS MISUSE TO THE SUBJECT METER. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED POWER ISSUE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26676 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3350813

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L