BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1092304 · Received August 1, 2008

    Report

    Report Number
    2939301-2008-01648
    Event Type
    Injury
    Date Received
    August 1, 2008
    Report Date
    July 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 ON (B)(6)2008 AND ALLEGED THAT HER ONE TOUCH ULTRAMINI METER WAS READING INACCURATELY ERRATIC. 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 (B)(6) 2008 AT 9:15 PM. SHE REPORTED OBTAINING RESULTS OF 545 MG/DL AND 189 MG/DL, PERFORMED ON THE SUBJECT METER WITHIN 20 MINUTES APART. SHE ALSO MENTIONED THAT AS A RESULT OF THE REPORTED ISSUE, SHE TOOK HER USUAL DOSE OF DIABETES MEDICATION (METFORMIN 500 MG). THE PT ALSO REPORTED THAT SHE EXPERIENCED BEING SWEATY AFTER THE ISSUE BEGAN. SHE DID NOT RECEIVE/REQUIRE ANY MEDICAL ATTENTION AND WAS NOT TESTED ON ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT AND THAT IT WAS CODED CORRECTLY TO MATCH THE CODE ON THE TEST STRIP VIAL. THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN THE EXPIRATION/DISCARD DATES. THE PT'S TESTING TECHNIQUE WAS REVIEWED TO BE CORRECT AND SHE WAS ALSO CLEANING THE PUNCTURE AREA PROPERLY. SHE WAS WALKED THROUGH TWO CONTROL SOLUTION TESTS (WITH SUBJECT STRIPS AND STRIP FROM NEW VIAL), WHICH PASSED WITHIN RANGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGED THAT SHE EXPERIENCED A SYMPTOM SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. SHE DID NOT RECEIVE ANY MEDICAL ATTENTION AND THE METER/STRIPS WERE WITHIN SPECIFICATION WITH THE CONTROL SOLUTION TEST. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2842928

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening