BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1242247 · Received November 19, 2008

    Report

    Report Number
    2939301-2008-03182
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    November 1, 2008
    Report Date
    November 1, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    THE LAY USER/PATIENT CONTACTED LIFESCAN IN 2008 AND ALLEGED THAT HER ONE TOUCH ULTRA METER WAS DISPLAYING THE BATTERY INDICATOR. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE PATIENT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE PATIENT REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED ON THAT DAY. SHE ALSO MENTIONED THAT SHE EXPERIENCED HIGH BLOOD SUGAR SYMPTOMS (SPECIFIC SYMPTOMS NOT PROVIDED) AFTER THE ISSUE BEGAN. AS A RESULT OF THE REPORTED ISSUE, THE PATIENT TOOK AN INCREASED DOSE OF HER INSULIN. SHE DID NOT RECEIVE ANY MEDICAL ATTENTION. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. BASED ON THE INFORMATION PROVIDED, THERE WAS NO MISUSE OF THE PRODUCT. IT WAS DETERMINED THAT THE PATIENT HAD NOT CHANGED THE BATTERY PER THE OWNER'S MANUAL (USER ERROR). THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED TO HAVE EXPERIENCED SYMPTOMS OF HIGH BLOOD GLUCOSE AFTER THE REPORTED ISSUE BEGAN. SHE INCREASED HER INSULIN DOSAGE AND DID NOT RECEIVE MEDICAL ATTENTION. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2632864

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization