BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3081693 · Received April 29, 2013

    Report

    Report Number
    3008382007-2013-09261
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 10, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    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. DATE OF EVENT: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING INACCURATELY HIGH READINGS. ON (B)(4) 2013 THE TECHNICAL SERVICE REPRESENTATIVE SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION. ON AN UNSPECIFIED DATE, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 108 MG/DL ON THE REPORTED METER WHICH SHE CLAIMED WAS INACCURATELY HIGH COMPARED TO HER EXPECTED VALUE OF 85 MG/DL. BASED ON THIS READING, THE PATIENT TOOK AN INCREASED DOSE OF 17.0 UNITS HUMALOG INSULIN. AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING AND SWEATING. WHILE SYMPTOMATIC, THE PATIENT TESTED HER BLOOD GLUCOSE LEVEL TO BE 52 MG/DL USING THE REPORTED METER. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING FOOD; SHE DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT REPORTED TWO ADDITIONAL ACCURACY COMPARISONS. ON AN UNSPECIFIED DATE, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 125 MG/DL ON THE REPORTED METER AND A LABORATORY RESULT OF 90 MG/DL. ON (B)(6) 2013 THE PATIENT OBTAINED THE READING OF 170 MG/DL ON THE REPORTED METER AND A READING OF 120 MG/DL ON ANOTHER METER WITHIN 30 MINUTES. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. IT IS NOT CLEAR WHY THE PATIENT TOOK AN INCREASED DOSE OF INSULIN BASED ON A NORMAL BLOOD GLUCOSE READING. HOWEVER, AS THE PATIENT SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON A METER READING AND RECEIVED TREATMENT WITH FOOD, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185631 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3385401

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Life Threatening| R