BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3171507 · Received June 15, 2013

    Report

    Report Number
    3008382007-2013-17363
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    June 9, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    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¿S MOTHER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRALINK METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT¿S MOTHER REPORTED THAT THE ALLEGED POWER ISSUE BEGAN ON THE MORNING OF (B)(6) 2013. THE PATIENT MANAGES HIS DIABETES WITH INSULIN. THE REPORTER CLAIMED THE PATIENT ATE FEWER CARBOHYDRATES AS A RESULT OF NOT BEING ABLE TO TEST HIS BLOOD GLUCOSE. APPROXIMATELY 8 HOURS AFTER THE POWER ISSUE STARTED, THE PATIENT DEVELOPED A HEADACHE. THE REPORTER DENIED THAT THE PATIENT RECEIVED MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE REPORTER CLAIMED THAT THE BATTERIES WITH THE SUBJECT METER HAD ¿EXPLODED¿. THE ALLEGED POWER ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED POWER ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272707 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR