BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2539434 · Received April 18, 2012

    Report

    Report Number
    2939301-2012-03813
    Event Type
    Malfunction
    Date Received
    April 18, 2012
    Report Date
    March 30, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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. THE 510(K) # IS K080639.

    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 DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE OCCURRED AT APPROXIMATELY 5:15PM ON THE SAME DAY SHE CONTACTED LFS FOR ASSISTANCE. THE PATIENT CLAIMED THAT APPROXIMATELY 25 MINUTES PRIOR TO THE ALLEGED ISSUE OCCURRING SHE WAS FEELING 'IRRITABLE.' THE PATIENT MANAGES HER DIABETES WITH INSULIN (UNKNOWN TYPE/DOSE) THROUGH PUMP THERAPY AND SHE DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION DUE TO THE ALLEGED ISSUE. IT WAS NOTED DURING THE INITIAL CALL THAT THE METER WAS NOT BEING USED FOR THE FIRST TIME AND THERE WERE NO REPORTS OF TRAUMA/MISUSE TO THE DEVICE. BASED ON THE ONETOUCH PING METER SPECIFICATIONS THE BATTERY WAS REPLACED RECENTLY, HOWEVER THE ISSUE REMAINED UNRESOLVED. THE PATIENT ATTEMPTED TO USE A TEST STRIP FROM A DIFFERENT LOT NUMBER AND STILL ENCOUNTERED THE SAME PROBLEM. A REPLACEMENT METER WAS SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT SINCE THE PATIENT SYMPTOMS DID NOT CORRELATE WITH LFS'S DEFINITION SUGGESTIVE OF A SERIOUS INJURY NOR DID SHE RECEIVE MEDICAL INTERVENTION. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3157464

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR