BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1060331 · Received June 13, 2008

    Report

    Report Number
    2939301-2008-01091
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/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 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 PATIENT/LAYPERSON SPOKE WITH A CUSTOEMR CARE ADVOCATE, CCA, ALLEGING HIS ONETOUCH ULTRAMINI METER WAS INACCURATELY LOW RESULTING IN TREATMENT FOR ELEVATED BLOOD GLUCOSE AT THE ER. THE CCA REPLACED ALL PRODUCTS. THIS SENIOR MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE PATIENT ON JUNE 12, 2008. ALL RESULTS ARE IN THE CORRECT UNIT OF MEASURE, MG/DL. THE PATIENT WEARS AN INSULIN PUMP AND TESTS UP TO SIX TIMES A DAY. REPORTEDLY, HIS RESULTS HAD BEEN "NORMAL" THE DAY BEFORE AND DAY OF THE INCIDENT. AT SOME POINT BEFORE BEING SYMPTOMATIC WITH NAUSEA, VOMITING AND DRY MOUTH, HIS BLOOD GLUCOSE WAS REPORTEDLY 150. HE REPORTEDLY TOOK NO INSULIN AFTER THE RESULT. WHEN HIS ALLEGED SYMPTOMS BEGAN THE AFTERNOON OF ORIGINAL DATE, A FRIEND DROVE THE PATIENT TO THE EMERGNCY ROOM. HIS BLOOD GLUCOSE WAS REPROTED "450 ON THE ER METER, 500 BY THE VENOUS DRAW, AND 150" ON HIS METER WITH A SAMPLE OF VENOUS BLOOD. THE PATIENT WAS REPORTEDLY TREATED WITH IV FLUIDS, IV INSULIN, AND PAIN MEDICATION AT THE ER. REPORTEDLY, WHEN HIS PHYSICIAN RAN CONTROL TESTS USING THE PATIENT'S CONTROL SOLUTION; THE RESULTS WERE OUT OF RANGE. THE PATIENT WAS RELEASED LATER THE SAME NIGHT. BECAUSE HIS PHYSICIAN KEPT THE PATIENT'S METER AND STRIPS, THE PATIENT WAS URGED TO INFORM THE PHYSICIAN THAT LIFESCAN WOULD LIKE TO EVALUATE THE PRODUCTS. BECAUSE THE PT ALLEGEDLY HAD SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA AFTER THE REPROTED ISSUE AND THEN WAS TREATED WITH IV FLUIDS, IV INSULIN IN AN ER, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R