BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC METER

    MDR report key: 1092844 · Received July 31, 2008

    Report

    Report Number
    2939301-2008-01611
    Event Type
    Injury
    Date Received
    July 31, 2008
    Report Date
    July 27, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A "POWER ISSUE" WITH THE ONETOUCH BASIC ORIGINAL METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT STATED THAT THE POWER ISSUE WITH THE SUBJECT METER BEGAN ON AN UNKNOWN DAY AT AROUND 11PM. DURING THAT TIME, THE PATIENT MENTIONED THAT THE SUBJECT METER WOULD NOT TURN ON. THE PATIENT REPORTEDLY DID NOT MAKE ANY CHANGES TO THE DIABETIC MEDICATIONS FOLLOWING THE ISSUE. THE PATIENT WAS UNABLE/UNWILLING TO ANSWER WHEN ASKED WHETHER HE EXPERIENCED ANY DIABETIC SYMPTOMS BEFORE, DURING OR AFTER THE ALLEGED ISSUE. THE PATIENT REPORTEDLY HAD A "HARD TIME SEEING." AFTER THE ALLEGED ISSUE, ON EARLY OF THE MONTH, THE PATIENT REPORTEDLY WAS ADMITTED IN THE HOSPITAL AND REPORTEDLY OBTAINED A READING OF "570MG/DL" ON THE ER/HOSPITAL'S METER. AT THE SAME TIME, HE REPORTEDLY WAS TREATED WITH IV (INTRAVENOUS) FLUIDS. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. THE PATIENT HAD REPLACED THE BATTERY PER THE OWNER'S MANUAL. THE BATTERY WAS CHECKED (GOOD CONDITION) AND IT WAS CORRECTLY INSTALLED. BASED ON THE INFORMATION PROVIDED, THERE WAS NO MISUSE OF THE PRODUCT. THE PATIENT'S PRODUCTS WERE REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. IN ADDITION, THE PATIENT CLAIMED THAT AFTER THE REPORTED ISSUE, HE OBTAINED A READING OF "570MG/DL" ON THE HOSPITAL'S METER AND WAS TREATED WITH IV FLUIDS, WHICH COULD BE SUGGESTIVE THAT HE SUFFERED A HYPERGLYCEMIC EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| L