BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3082054 · Received April 29, 2013

    Report

    Report Number
    3008382007-2013-09371
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 4, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE STARTED ON (B)(6) 2013 AT 9AM. IT IS NOT KNOWN IF SHE MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED POWER ISSUE. HOWEVER, THE PATIENT REPORTED DEVELOPED SYMPTOM(S) OF 'HIGH BLOOD' ONE AFTER THE ALLEGED POWER ISSUE STARTED AND CLAIMED SHE TOOK AN INCREASE DOSE OF INSULIN AT APPROXIMATELY THE SAME TIME FRAME SHE DEVELOPED THE SYMPTOM(S). AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER¿S BATTERY DID NOT NEED TO BE REPLACED. THE ALLEGED POWER ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185715 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Life Threatening| R