BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3141381 · Received June 3, 2013

    Report

    Report Number
    3008382007-2013-14074
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 6, 2013
    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
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER ASSOCIATED WITH THIS COMPLAINT HAS BEEN RETURNED TO LIFESCAN; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONE TOUCH PING METER WAS DISPLAYING THE AN ¿ERROR 5¿ MESSAGE. PER THE OWNER¿S BOOKLET, AN ERROR 5 APPEARS WHEN THE METER HAS DETECTED A PROBLEM WITH THE TEST STRIP. POSSIBLE CAUSES ARE TEST STRIP DAMAGE OR AN INCOMPLETELY FILLED CONFIRMATION WINDOW. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT ALLEGED THE ISSUE FIRST OCCURRED AT (B)(6) 2013 AT 2:30 P.M. IT IS NOT KNOWN IF THE PATIENT TAKES MEDICATION TO MANAGE HIS DIABETES OR IF HE MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. THIRTY MINUTES PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿YAWNING PROFUSELY, TIRED¿. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS APPLYING THE BLOOD SAMPLE CORRECTLY AND NOTED THAT THE PATIENT CONFIRMED THAT THE TEST STRIPS DREW IN THE SAMPLES. HOWEVER THE ALLEGED METER ISSUE REMAINED UNRESOLVED AT THE TIME OF THE CALL. 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 METER ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243744 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3247715

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR