BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1092883 · Received July 31, 2008

    Report

    Report Number
    2939301-2008-01607
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 24, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRA METER WAS READING INACCURATELY LOW WHEN COMPARED TO ANOTHER METER. THE COMPLAINT WAS BASED ON THE CUSTOMER SERVICE REPRESENTATIVE'S (CSR) DOCUMENTATION. THE PATIENT REPORTS A BLOOD GLUCOSE READING OF "135 MG/DL" ON THE DAY BEFORE AT 10:30 AM, THEN HAD HER USUAL BREAKFAST AND TOOK THE USUAL 30 UNITS OF LANTUS AFTER EATING. LATER ON THE SAME DAY AT 3:30 PM, THE PATIENT VISITS HER HEALTHCARE PROFESSIONAL (HCP) FOR UNKNOWN REASON AND A BLOOD GLUCOSE TEST OF "336 MG/DL" WAS REPORTEDLY OBTAINED ON THE HCP'S METER. ALTHOUGH THE PATIENT WAS REPORTEDLY ASYMPTOMATIC, SHE MENTIONS BEING TREATED WITH 30 UNITS OF AN UNSPECIFIED TYPE OF INSULIN. SHE USUALLY TESTS HER BLOOD GLUCOSE TWO TIMES A DAY: BEFORE HAVING BREAKFAST AND BEFORE BEDTIME. SHE ALSO MANAGES HER DIABETES WITH INSULIN TAKEN ON A FIXED SCALE REGARDLESS OF METER READINGS. THE UNIT OF MEASURE WAS SET CORRECTLY TO MG/DL AT THE TIME OF TESTING. THE PATIENT USED THE CORRECT TESTING TECHNIQUE AND PROPER CLEANING OF THE PUNCTURE SITE TO TEST HER BLOOD GLUCOSE WITH. THE CSR VERIFIED THE FOLLOWING INFORMATION: THE RESULTS IN THE METER'S MEMORY DID NOT MATCH. BECAUSE THE READINGS ON BOTH METERS WERE TAKEN OVER 30 MINUTES APART (LFS CRITERIA FOR ACCURACY AND PRECISION TESTING), THERE IS INSUFFICIENT INFORMATION TO INDICATE THAT THE METER HAD MALFUNCTION. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION BY THE HCP AFTER THE ALLEGED METER ISSUE BEGAN. THE PATIENT'S PRODUCTS HAVE BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2827547

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention