BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SURESTEP ENHANCED METER

    MDR report key: 2920310 · Received January 17, 2013

    Report

    Report Number
    3008382007-2013-01058
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    January 4, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH SURESTEP ENHANCED METER READ 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 CCA NOTED THAT THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE STARTED ON (B)(6) 2003. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF MEDICATIONS (TYPE UNKNOWN). IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE ALLEGED METER ISSUE. THE PATIENT REPORTED THAT A COUPLE OF MONTHS AFTER THE ISSUE STARTED SHE DEVELOPED SYMPTOMS OF SHAKY AND SWEATY AND WAS TREATED WITH IV GLUCOSE IN THE ER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT REPLACED THE METER¿S BATTERY; HOWEVER, THE POWER ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY WAS TREATED FOR SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER OBTAINING THE ALLEGED METER ISSUE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26024 OT SURESTEP ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R