BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 3083153 · Received April 29, 2013

    Report

    Report Number
    3008382007-2013-09394
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 18, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    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 (B)(6) 2013, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE ONETOUCH VITA METER IS GIVING INACCURATE READINGS OF "145 AND 118 MG/DL" COMPARED TO NORMAL READING/FEELING. THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE. THE PATIENT'S DIABETES IS MANAGED WITH SELF ADJUSTING INSULIN. ACCORDING TO THE PATIENT, SHE RECEIVED THE ALLEGED INACCURATE HIGH READINGS ON (B)(6) 2013 AT 4:54 PM AND INCREASED HER INSULIN ACCORDINGLY AND ATE FOOD. THE PATIENT NOTED THAT THE READING OF "145 MG/DL" WAS HIGHER THAN NORMAL. WITHIN 5 MINUTES OF THE INSULIN INTAKE, THE PATIENT DEVELOPED SYMPTOMS DESCRIBED AS "SWEAT AND FEELING SHAKY." DURING TROUBLESHOOTING, THE PATIENT CONFIRMED THE UNIT OF MEASUREMENT WAS CORRECTLY SET. THERE WAS NO CONTROL SOLUTION AT THE TIME TO PERFORM A QUALITY TEST. THE TEST STRIPS WERE WITHIN THE DISCARD DATE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER SHE TOOK INSULIN BASED ON THE ALLEGED ELEVATED BLOOD GLUCOSE. THE LFS PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185435 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3402417

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening