BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3022027 · Received March 26, 2013

    Report

    Report Number
    3008382007-2013-06278
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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 TO REPORT THE ONE TOUCH VERIO IQ 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 2:09 AM THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 307 MG/DL ON THE REPORTED METER, WHICH SHE CLAIMED WAS INACCURATELY HIGH COMPARED TO HER EXPECTED VALUES. BASED ON THIS READING, THE PATIENT TOOK AN INCREASED DOSE OF INSULIN, 30 UNITS HUMALOG INSULIN. THREE AND A HALF HOURS AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF SHAKING. SHE DID NOT REPORT RECEIVING ANY TREATMENT FOR THIS SYMPTOM. TROUBLESHOOTING REVEALED THE PATIENT'S TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. A QUALITY CONTROL TEST WAS PERFORMED DURING THE CALL, WITH PASSING RESULTS. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING AN INCREASED DOSE OF INSULIN BASED ON AN ELEVATED METER READING. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123093 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3317947

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening