BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1060335 · Received June 13, 2008

    Report

    Report Number
    2939301-2008-01086
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 3, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D 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/PT CONTACTED LIFESCAN ALLEGING A POWER ISSUE WITH ONE TOUCH ULTRA2 METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE MEDICAL AFFAIRS SPECIALIST (MAF) WAS UNABLE TO CORRESPOND WITH THE PT BY PHONE. THE MAS MAILED A LETTER TO THE PT ON JUNE 11, 2008. THE PT TESTS HIS BLOOD GLUCOSE 3 TIMES A DAY AND MANAGES HIS DIABETES VIA ORAL DIABETIC PILLS. THE PT STATED THAT THE ALLEGED METER ISSUE BEGAN ON ORIGINAL DATE AT 6:40 AM. AFTER THE ALLEGED ISSUE BEGAN WITH THE METER, THE PT REPORTEDLY EXPERIENCED SYMPTOMS OF "LIGHTHEADEDNESS AND THIRSTINESS". THE PT REPORTEDLY TOOK NO DIABETES TREATMENT ACTIONS FOLLOWING THE ISSUE AND DID NOT RECEIVE/REQUIRE ANY MEDICAL TREATMENT FOR THE DIABETES. HE WAS NOT TESTED ON ANY OTHER METER. DURING THE TROUBLESHOOTING, THE CCA FOUND OUT THE FOLLOWING: THE CUSTOMER REPLACED THE BATTERIES PER THE OWNER'S MANUAL, THE BATTERIES WERE IN GOOD CONDITION, THE PT WAS USING THE CORRECT TEST STRIPS, THE METER WAS NOT DOWNLOADED PRIOR TO TESTING AND THE METER WOULD NOT TURN ON EVEN AFTER INSERTING THE TEST STRIP ALL THE WAY INTO THE TEST STRIP PORT. REPLACEMENT PRODS WERE SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGES THAT THE METER WOULD NOT POWER ON, AND IT WAS NOT RESOLVED DURING THE TROUBLESHOOTING. IN ADDITION, THE PT REPORTEDLY EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2821473

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening