BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2030005 · Received March 25, 2011

    Report

    Report Number
    2939301-2011-02638
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Report Date
    March 9, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. 510(K) # IS K082590.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH PING METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT APPROXIMATELY 7:00PM. THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "62, 45, AND BELOW 20 MG/DL" WITH THE SUBJECT METER, PERFORMED AT AN UNKNOWN TIME OF EACH OTHER. ALTHOUGH, THE TIME DIFFERENCE WAS NOT SPECIFIED, THE CCA DOCUMENTED THAT THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. PER THE CCA DOCUMENTATION, THE PATIENT WAS NOT ABLE TO SPECIFY WHETHER THE PATIENT WAS TAKING ANY DIABETES MEDICATIONS OR WHETHER ANY ACTION WAS TAKEN REGARDING HIS DIABETES REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE CCA HOWEVER WAS ABLE TO DOCUMENT THAT THE PATIENT REPORTEDLY WAS FEELING "CRAPPY", WEAK, AND RUN DOWN PRIOR TO THE START OF THE ALLEGED ISSUE. IN RESPONSE TO HIS SYMPTOMS, THE CCA NOTED THE PATIENT TREATED HIMSELF WITH FOOD AND/OR DRINK. AROUND THE SAME TIME THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED HE TESTED ON ANOTHER METER (ONETOUCH ULTRA) AND OBTAINED A READING OF "480 MG/DL". AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT'S PROCESS FOR TESTING WAS CORRECT, THE RESULTS OBTAINED WERE FROM THE SAME APPROVED SAMPLE SITE, AND THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY. THE PATIENT WAS ABLE TO PERFORM A QUALITY CONTROL SOLUTION TEST; HOWEVER THE RESULT DID NOT FALL WITHIN THE SPECIFIED RANGE ON THE VIAL OF TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT FELT SYMPTOMATIC PRIOR TO OBTAINING THE ALLEGED ISSUE. IN ADDITION, THERE IS NO EVIDENCE OF DELAY IN TREATMENT. THEREFORE THE METER DID NOT CONTRIBUTE TO THE PATIENT'S SYMPTOM. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED 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. 3052140

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR