BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2902834 · Received January 9, 2013

    Report

    Report Number
    3008382007-2013-00295
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 13, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING HER ONETOUCH PING METER WAS POWERING OFF WHEN ATTEMPTING A TEST. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON THE SAME DAY SHE CONTACTED LFS FOR ASSISTANCE AT APPROXIMATELY 12:45PM. THE PATIENT REPORTED THAT SHE MANAGES HER DIABETES WITH INSULIN THROUGH PUMP THERAPY AND IT IS NOT KNOW IF SHE MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. SHE CLAIMED THAT PRIOR TO THE ISSUE OCCURRING SHE WAS EXPERIENCING LOW BLOOD GLUCOSE SYMPTOMS OF "HEART RACING, ADRENALINE RUSH AND FELT FUZZY" AND DESPITE HER SYMPTOM, SHE DENIED RECEIVING ANY TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME; THE ISSUE CONTINUED AFTER REPLACING WITH NEW BATTERIES. THE ISSUE REMAINED UNRESOLVED AND REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S SYMPTOMS STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED. THERE WAS NO INDICATION THAT THE PATIENT'S SYMPTOMS DETERIORATED SINCE THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION AFTER THE PRODUCT ISSUE OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10839 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3351243

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR