BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1163081 · Received September 15, 2008

    Report

    Report Number
    2939301-2008-02258
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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

    THE LAY USER/PT CONTACTED LIFESCAN IN 2008 AND ALLEGED THAT HER ONE TOUCH ULTRA2 METER WAS NOT POWERING ON. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE PT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE PT REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED ON THE EVENT DATE, BETWEEN 10:30-11:00 AM. AS A RESULT OF THE REPORTED ISSUE, SHE ALLEGEDLY TOOK DIABETES MEDICATION (HUMALOG INSULIN 25 UNITS) BASED ON A SLIDING SCALE. HOWEVER, IT IS UNCLEAR AS TO WHICH RESULT SHE HAD BASED THE INSULIN DOSAGE ON. SHE REPORTED TESTING ON ANOTHER METER (ACCUCHEK COMPACT) WITH A RESULT OF 62 MG/DL. IT IS NOT KNOWN WHEN THIS TEST WAS PERFORMED. THE PT MENTIONED THAT AFTER THE REPORTED ISSUE BEGAN, SHE FELT SHAKY (UNK THE EXACT TIME THE SYMPTOMS BEGAN AFTER THE ISSUE). THE PT DID NOT RECEIVE/REQUIRE ANY MEDICAL ATTENTION. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. BASED ON THE INFO PROVIDED, THERE WAS NO MISUSE OF THE PRODUCT. THE PT WAS USING THE CORRECT TEST STRIPS. HOWEVER, THE METER TURNED ON WHEN THE POWER BUTTON WAS PRESSED AND WHEN THE TEST STRIP WAS INSERTED ALL THE WAY INTO THE TEST STRIP PORT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED THAT SHE EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. SHE ALSO TOOK INSULIN AS A RESULT OF THE REPORTED ISSUE, HOWEVER, IT IS NOT KNOWN WHAT THE DOSAGE WAS BASED ON. SHE DID NOT RECEIVE ANY MEDICAL ATTENTION. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2810201

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening