BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING METER

    MDR report key: 1770417 · Received May 13, 2010

    Report

    Report Number
    2939301-2010-03774
    Event Type
    Malfunction
    Date Received
    May 13, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 4, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVAL. 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.

    Description of Event or Problem · 1

    THE LAY USER/PT CONTACTED LFS ON (B)(6) 2010, ALLEGING INACCURATE ERRATIC READINGS ON THEIR ONE TOUCH PING METER. THE PT MENTIONED PRIOR TO TESTING ON (B)(6) 2010, THE PT FELT A LITTLE SHAKY. APPROX 30 MINS LATER, THE PT TESTED AND OBTAINED THE FOLLOWING RESULTS: 119 MG/DL AT 1:02 PM, A 303 MG/DL AT 12:57 PM AND A 65 MG/DL AT 12:39 PM. THE READINGS WERE TAKEN GREATER THAN 20 MINS APART FROM ONE ANOTHER. THE PT WENT AHEAD AND SELF-TREATED WITH SODA. THE PT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE PT WAS NOT TESTED ON ANOTHER DEVICE. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PT DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCT WAS REPLACED. AT THIS TIME THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT SINCE THE PT EXHIBITED SYMPTOMS PRIOR TO TESTING AND SYMPTOMS CORRELATED WITH SELF-TREATMENT. THE COMPLAINT IS BEING REPORTED SINCE THE PT'S SYMPTOMS DID NOT CORRELATE WITH READINGS (119 MG/DL AND 303 MG/DL) THAT THEY OBTAINED ON THE PING METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2999838

    Patients

    Seq Age Sex Outcome Treatment
    1