BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 2983553 · Received February 28, 2013

    Report

    Report Number
    3008382007-2013-03814
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 25, 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
    FR
    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 (04/16/2013)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS FAILED TESTING. THE TEST STRIP VIAL WAS EXPOSED TO MOISTURE AND DURING CONTROL SOLUTION TESTING AN ERROR 5 MESSAGE WAS OBSERVED. THE METER HAVE ALSO BEEN RETURNED TO LFS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED TESTING, NO FAULTS WERE FOUND, AND FUNCTIONED PROPERLY.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 HEALTHCARE PROFESSIONAL/REPORTER, A PHARMACIST, CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VITA METER WAS GIVING INACCURATELY HIGH READINGS. ON (B)(4) 2013 THE TECHNICAL SERVICE REPRESENTATIVE SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION. THE PATIENT REPORTED THAT WITHIN A SEALED BOX OF FOUR TEST STRIP VIALS, ONE VIAL'S CAP WAS BROKEN. THE PATIENT CHOSE TO USE THIS BROKEN VIAL OF TEST STRIPS FIRST OUT OF THE BOX. ON (B)(6) 2013 AT 6:50 AM, THE PATIENT OBTAINED THE FASTING BLOOD GLUCOSE LEVEL OF 249 MG/DL ON THE REPORTED METER, WHICH SHE CLAIMED WAS INACCURATELY HIGH COMPARED TO HER EXPECTED VALUES OF 90 MG/DL TO 100 MG/DL. BASED ON THIS READING, THE PATIENT TOOK AN INCREASED DOSE OF NOVORAPID INSULIN 7.0 UNITS INSTEAD OF 4.0 UNITS. THE PATIENT ATE HER USUAL BREAKFAST AFTERWARDS. AT NOON, PRE-LUNCH, THE PATIENT OBTAINED THE READING OF 97 MG/DL USING THE SAME VIAL OF TEST STRIPS. THE PATIENT STARTED TO EXPERIENCE THE SYMPTOMS OF SHAKING AND HUNGER. THE PATIENT TESTED HER BLOOD GLUCOSE LEVEL USING ANOTHER VIAL OF TEST STRIPS, AND OBTAINED A READING OF 38 MG/DL. THE PATIENT ADMINISTERED SELF-TREATMENT BY EATING RICE AND PASTA; SHE DID NOT SEEK ANY MEDICAL ATTENTION. IF THE TEST STRIP VIAL WAS BROKEN, THE TEST STRIPS MAY HAVE BEEN COMPROMISED AND CONTRIBUTED TO INACCURATE READINGS. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING AN INCREASED DOSE OF INSULIN BASED ON AN ELEVATED METER READING, AND RECEIVED SELF-TREATMENT WITH FOOD. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88187 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3246640

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R