BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1082190 · Received July 24, 2008

    Report

    Report Number
    2939301-2008-01496
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    July 19, 2008
    Report Date
    July 19, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONETOUCH ULTRASMART METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION SINCE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO CONTACT THE PT TO OBTAIN ADD'L INFO. ON THE SAME DAY AT 10:34 AM, THE PT REPORTEDLY OBTAINED BLOOD GLUCOSE "484 MG/DL" ON THE SUBJECT METER AND REPORTEDLY TOOK 7 UNITS OF APIDRA IN ADDITION TO BEING ON THE INSULIN PUMP (UNSPECIFIED TYPE). AT AN UNSPECIFIED TIME AFTER THE REPORTED METER ISSUE, THE PT REPORTEDLY FELT "SHAKY AND NERVOUS". THERE WAS NO MENTIONING WHETHER THE PT SOUGHT MEDICAL INTERVENTION OR TREATED HERSELF BASED ON THE ALLEGED SYMPTOMS. THE UNIT OF MEASUREMENT WAS SET CORRECTLY TO MG/DL AT THE TIME OF TESTING. THE MEMORY IN THE METER MATCHED. A CONTROL SOLUTION TEST WAS PERFORMED AND THE RESULT FELL WITHIN THE SPECIFIED RANGE. THE TESTING TECHNIQUE AND CLEANING OF THE PUNCTURE AREA WAS CORRECT AT THE TIME OF TESTING. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING REASON: THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. THE PT'S PRODUCTS HAVE BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2729828

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening