BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2922369 · Received January 18, 2013

    Report

    Report Number
    3008382007-2013-01072
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 8, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 METER WAS DISPLAYING AN "ER2" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2013, AT AN UNKNOWN TIME IN THE MORNING. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH AN UNKNOWN TYPE OF INSULIN THROUGH PUMP THERAPY AND SHE DENIED TAKING ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. APPROXIMATELY 4 HOURS LATER, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF FEELING "SWEATY, SHAKY, AND HOT" AND DESPITE HER SYMPTOMS, SHE DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION. DURING TROUBLESHOOTING, THE CCA CONFIRMED THE CORRECT TEST STRIPS AND TESTING PROCEDURE WAS USED, HOWEVER, THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND THE SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27685 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3347380

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening