BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH FASTTAKE METER

    MDR report key: 1192403 · Received October 15, 2008

    Report

    Report Number
    2939301-2008-02549
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 2, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER'S/ PATIENT'S WIFE CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH FASTTAKE METER HAD A "POWER ISSUE." THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT TESTS HIS BLOOD SUGAR ONE TIME PER DAY, AND HE MANAGES HIS DIABETES VIA SOME OTHER METHOD OF TREATMENT (UNK). THE PATIENT IS NOT USING INSULIN OR ORAL DIABETIC PILLS. THE PATIENT'S WIFE STATED THAT THE ALLEGED ISSUE BEGAN A MONTH PRIOR TO CONTACTING THE LFS (DATE AND TIME UNK). DURING THAT TIME, IT WAS NOTED THAT THE SUBJECT METER "WOULD NOT POWER ON." IT IS NOT KNOWN HOW HE MANAGED HIS DIABETES AFTER THE REPORTED ISSUE. THE PATIENT DID NOT TAKE ANY DIABETIC TREATMENT ACTIONS FOLLOWING THE REPORTED ISSUE. AT AN UNSPECIFIED TIME, AFTER THE REPORTED ISSUE, THE PATIENT REPORTEDLY EXPERIENCED SYMPTOMS OF "TIREDNESS." IT IS NOT KNOWN WHETHER THE PATIENT OBTAINED ANY BLOOD GLUCOSE READINGS WHILE EXPERIENCING THE SYMPTOMS. A WEEK PRIOR TO CONTACTING THE LFS (DATE AND TIME UNK), HE REPORTEDLY WAS TAKEN TO THE HOSPITAL AND TESTED "OVER 400MG/DL" ON THE HOSPITAL'S METER. THE PATIENT REPORTEDLY WAS TREATED WITH 45 UNITS OF INSULIN (UNK TYPE). AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. THE PATIENT WAS USING THE CORRECT TEST STRIP. IT WAS NOTED THAT THE BATTERIES WERE MISSING FROM THE METER. HOWEVER, THE METER WOULD NOT TURN ON AFTER REPLACING THE BATTERIES. THE ISSUE WAS NOT RESOLVED WHEN THE POWER BUTTON WAS PRESSED OR WHEN THE TEST STRIP WAS INSERTED ALL THE WAY INTO THE TEST STRIP PORT. THE PATIENT'S METER WAS REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED POWER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. IN ADDITION, THE PATIENT'S WIFE CLAIMED THAT AFTER THE REPORTED ISSUE, HE OBTAINED A READING OF "OVER 400MG/DL" ON THE HOSPITAL'S METER AND WAS TREATED WITH 45 UNITS OF INULIN, WHICH COULD BE SUGGESTIVE OF A HYPERGLYCEMIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH FASTTAKE METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 1013952

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening