BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 796022 · Received December 9, 2004

    Report

    Report Number
    2939301-2004-06162
    Event Type
    Malfunction
    Date Received
    December 9, 2004
    Report Date
    December 2, 2004
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    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 EVALUTE 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 PT CALLED LIFESCAN ON 12/02/2004 AND ALLEGED THAT HIS METER WAS READING INACCURATELY ERRATIC. THE PT REPORTED RESULTS OF 38, 251, 231, 192, AND 251 MG/DL. THE TESTS WERE PERFORMED WITHIN 10 MINUTES AND THE COMPARISON FALLS OUTSIDE OF THE 20% SPECIFICATIONS. HOWEVER, THE PT ALSO REPORTED THAT THE TEST STRIPS WERE DAMAGED (NO SPECIFICS AS TO HOW THEY WERE DAMAGED). THE PATIENT ATE AND DRANK AFTER TESTING, BUT HE DID NOT RECEIVE ANY MEDICAL ATTENTION. THE TENCHNIQUES FOR APPLYING THE BLOOD TO THE TEST STRIP AND FOR CLEANING THE PUNCTURE SITE WERE CORRECT. BASED ON THE INFORMATION PROVIDED, THERE IS EVIDENCE OF A TEST STRIP MALFUNCTION; HOWEVER, THERE IS NO EVIDENCE OF THE METER CONTRIBUTING TO A SERIOUS INJURY. A REPLACEMENT METER AND TESTING SUPPLIES ARE BEING SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2526423

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN