BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2030004 · Received March 25, 2011

    Report

    Report Number
    2939301-2011-02636
    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 LOW COMPARED TO ANOTHER METER . 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 BELOW "20 MG/DL" WITH THE SUBJECT METER AND "480 MG/DL" ON ANOTHER METER(ONETOUCH ULTRA METER), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. IT IS NOT KNOWN IF THE PATIENT WAS MANAGING HIS DIABETES AT THE TIME THE ALLEGED ISSUE BEGAN; HOWEVER INDICATED HE ADMINISTERED AN UNSPECIFIED TYPE AND DOSE OF INSULIN BASED ON THE READING OF "480 MG/DL" ON THE OTHER DEVICE. PRIOR TO TESTING HIS BLOOD GLUCOSE, THE PATIENT REPORTEDLY FELT "CRAPPY", WEAK, AND RUN DONE. IT IS NOT KNOWN IF THE PATIENT RECEIVED ANY MEDICAL TREATMENT AFTER THE ALLEGED BEGAN SINCE THE PATIENT REFUSED TO PROVIDE ADDITIONAL INFORMATION AND DISCONNECTED THE CALL. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY, THE PATIENT PROCESS FOR TESTING WAS CORRECT, AND THE RESULTS OBTAINED WERE FROM AN APPROVED SAMPLE SITE. THE PATIENT WAS ABLE TO PERFORM A CONTROL SOLUTION TEST; WHICH RESULTED WITHIN THE SPECIFIED RANGE ON THE VIAL OF TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. 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 MEDICAL TREATMENT FOR ACUTE COMPLICATIONS OF DIABETES. 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