BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING METER

    MDR report key: 1713268 · Received June 3, 2010

    Report

    Report Number
    2939301-2010-04239
    Event Type
    Injury
    Date Received
    June 3, 2010
    Date of Event
    May 10, 2010
    Report Date
    May 12, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/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

    ON (B) (6), 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT THE ONE TOUCH PING METER WAS GIVING INACCURATELY ERRATIC READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B) (6), 2010 THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 146 MG/DL ON THE REPORTED METER, FOR WHICH HE RECEIVED AN INCREASED DOSE OF INSULIN VIA HIS PUMP, AS THE RESULT WAS GREATER THAN 120 MG/DL. ONE MINUTE LATER, THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF 103 MG/DL ON THE REPORTED METER. TWO HOURS AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF SHAKING. THE PATIENT DID NOT REPORT RECEIVING ANY TREATMENT FOR THIS SYMPTOM. THE PATIENT REPORTED ADDITIONAL PRECISION TESTING RESULTS OBTAINED ON (B) (6), 2010: 139 MG/DL AND 99 MG/DL WITHIN 20 MINUTES OF EACH OTHER. TROUBLESHOOTING REVEALED THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING AND THE PATIENT'S TESTING TECHNIQUE WAS CORRECT. THE METER WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON AN ELEVATED METER READING. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2986515

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening