BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1821621 · Received August 31, 2010

    Report

    Report Number
    2939301-2010-07407
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Report Date
    August 26, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6), 2010 ALLEGING INACCURATE HIGH READINGS ON HER ONE TOUCH PING METER. THE PATIENT MENTIONED THAT APPROXIMATELY 2-3 WEEKS AGO, SHE OBTAINED A 325 MG/DL ON THE ONE TOUCH PING METER AND LESS THAN 30 MINUTES LATER THE PATIENT OBTAINED A 200 MG/DL ON THE ONE TOUCH MINI METER. APPROXIMATELY 20 MINUTES LATER SHE DEVELOPED A HEADACHE. SHE DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN AND THE TEST STRIPS WERE NOT EXPIRED. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT 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 SYMPTOMS ARE NOT SUGGESTIVE OF A SERIOUS INJURY. THE COMPLAINT IS BEING REPORTED SINCE BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN THE 2 METER RESULTS ARE GREATER THAN 30 MG/DL OR 30%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 2905425

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR