BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2044552 · Received April 7, 2011

    Report

    Report Number
    2939301-2011-02891
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Report Date
    March 24, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (05/10/2011)-DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER 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 9:00PM. THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "115, 232, 110, 253, AND 259 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. IT IS NOT KNOWN IF THE PATIENT WAS TAKING ANY DIABETES MEDICATIONS OR IF THE PATIENT TOOK ACTION REGARDING HER DIABETES MANAGEMENT ROUTINE AS A RESULT OF THE ALLEGED ISSUE. PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT STATED SHE WAS FEELING TIRED. THE PATIENT HOWEVER DENIED SEEKING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT'S PROCESS FOR TESTING WAS CORRECT, THE SUBJECT METER'S UNIT OF MEASURE WAS CORRECT, AND THE RESULTS OBTAINED WERE FROM THE SAME APPROVED SAMPLE SITE. A QUALITY CONTROL SOLUTION TEST WAS NOT PERFORMED SINCE THE PATIENT DID NOT HAVE THE SOLUTION AVAILABLE. 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 INACCURATE RESULTS. IN ADDITION, THERE WAS NO MEDICAL TREATMENT FOR AN ACUTE COMPLICATION OF DIABETES. THEREFORE THE METER DID NOT CONTRIBUTE TO THE PATIENT'S SYMPTOMS. 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. 3059587

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR