BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 3142776 · Received June 3, 2013

    Report

    Report Number
    3008382007-2013-14695
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 31, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (07/01/2013).THE PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 6/20/2013 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 6/22/2013 AND 6/24/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VITA METER WAS GIVING INACCURATELY HIGH READINGS. THE SR MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013 AT 11:45 AM, THE PATIENT OBTAINED THE PRE-MEAL BLOOD GLUCOSE READING OF 216 MG/DL ON THE REPORTED METER, WHICH HE CLAIMED WAS INACCURATELY HIGH COMPARED TO HIS EXPECTED VALUES. BASED ON THIS READING THE PATIENT TOOK 10.0 UNITS ACTRAPID INSULIN. AT 1:00 PM THE PATIENT EXPERIENCED THE SYMPTOM OF SWEATING. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING GLUCOSE, AND FELT BETTER AFTERWARDS. HE DID NOT SEEK ANY MEDICAL ATTENTION. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON AN ELEVATED METER READING, AND RECEIVED TREATMENT WITH GLUCOSE TO ALLEVIATE HIS SYMPTOMS. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244519 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3388560

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R