BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC ENHANCED METER

    MDR report key: 1131897 · Received August 19, 2008

    Report

    Report Number
    2939301-2008-01906
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 11, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STIRPS 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 BASIC ENHANCED METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. ON THE SAME DAY AT AROUND 7 PM, THE PT REPORTEDLY OBTAINED BLOOD GLUCOSE "178 MG/DL" ON A LFS METER, WHICH HE CLAIMED WAS INACCURATELY HIGH COMPARED TO HIS NORMAL FEELINGS. THE PT REPORTEDLY DEVELOPED SYMPTOMS OF "WEAK AND SWEATS" SOMETIME AFTER THE REPORTED METER ISSUE BEGAN BUT REPORTEDLY DID NOT TREAT HIMSELF "IN ANY WAY." AS A RESULT, THE PT REPORTEDLY TOOK NO ACTION REGARDING HIS DIABETES REGIMEN BUT CALLED LFS TO REPORT THE ALLEGED METER ISSUE AN HOUR LATER. THE PT USUALLY TESTS HIS BLOOD SUGAR TWICE A DAY AND MANAGES HIS DIABETES WITH INSULIN (USUALLY REQUIRING NO DOSE ADJUSTMENTS). THE UNIT OF MEASUREMENT WAS SET CORRECTLY TO MG/DL AT THE TIME OF TESTING. THE MEMORY IN THE METER DOES NOT MATCH. THE TESTING TECHNIQUE AND CLEANING OF THE PUNCTURE AREA WAS CORRECT AT THE TIME OF TESTING. THE PATIENT'S PRODUCTS HAVE BEEN REPLACED. ALTHOUGH THERE WAS NO INDICATION THAT THE ALLEGED METER HAD MALFUNCTIONED BECAUSE THE REPORTED INACCURATE READINGS WERE COMPARED TO THE PATIENT'S FEELINGS"; THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED THAT HE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA, AFTER THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH BASIC ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 28277837

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening