BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1444807 · Received August 18, 2009

    Report

    Report Number
    2939301-2009-05161
    Event Type
    Injury
    Date Received
    August 18, 2009
    Date of Event
    July 17, 2009
    Report Date
    July 26, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON JULY 26, 2009 THE LAY USER/REPORTER CONTACTED LIFESCAN ON BEHALF OF THE LAY USER/PATIENT ALLEGING THE ONE TOUCH ULTRA MINI METER READ IMPRECISELY. THE MEDICAL SURVEILLANCE SPECIALIST WAS UNABLE TO CONTACT THE PATIENT TO OBTAIN/CLARIFY INFORMATION. THE REPORTER REPORTED READINGS OF 108, 111,134, 138, 139, 115, 104, 162, 134, 109, 122, AND 179 MG/DL WITH 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL CRITERIA, THE DIFFERENCE BETWEEN THE RESULTS FALLS WITHIN THE EXPECTED VALUE OF <=20%. THOSE READINGS WERE TAKEN BETWEEN 1:37 AM AND 1:56 AM AT AN UNKNOWN DATE CLOSE TO THE DATE OF THE CALL TO LIFESCAN. THE REPORTER SAID THE READINGS HAVE BEEN IMPRECISE FOR THE LAST TWO MONTHS. ON JULY 17 AT APPROXIMATELY 8 PM, THE PATIENT ALLEGEDLY FELT VERY BAD AFTER EATING, WAS NAUSEOUS, DIZZY, PASSED OUT, AND VOMITED REQUIRING AN AMBULANCE AND HOSPITALIZATION. THE PATIENT WAS TREATED WITH IV FLUIDS BY THE HOSPITAL. THE PATIENT WAS TESTED ON AN ER/HOSPITAL METER ON JULY 18 IN THE AFTERNOON BUT THE RESULTS ARE UNKNOWN. IT IS NOTED THAT THE PATIENT CONTROLS HER DIABETES WITH DIET AND EXERCISE AND DID NOT TAKE ANY ACTION REGARDING MANAGEMENT OF DIABETES BASED ON THE PERCEIVED IMPRECISE RESULTS. IT WOULD BE HELPFUL TO KNOW WHETHER THE PATIENT WOULD HAVE EATEN DIFFERENTLY OR OTHERWISE MANAGED HER DIABETES DIFFERENTLY HAD SHE NOT PERCEIVED AN IMPRECISION. IT WOULD ALSO BE HELPFUL TO KNOW WHAT READINGS THE PATIENT OBTAINED PRIOR TO SUFFERING SYMPTOMS. IT WAS DETERMINED DURING THE TROUBLESHOOTING TELEPHONE CALL, THE PATIENT'S TESTING TECHNIQUE WAS INCORRECT. THE TEST STRIPS WERE WITHIN EXPIRATION DATING AND IN GOOD CONDITION. THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THE CALIBRATION CODE ON THE METER MATCHED THE CODE ON THE TEST STRIP VIAL. THIS COMPLAINT IS BEING REPORTED BECAUSE IT WAS ALLEGED THAT THE METER READ IMPRECISELY AND THAT THE PATIENT SUFFERED SYMPTOMS INDICATIVE OF HYPOGLYCEMIA AFTER THE ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2922983

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening| R