BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3123076 · Received May 21, 2013

    Report

    Report Number
    3008382007-2013-12428
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 15, 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
    GM
    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. GENDER: NOT PROVIDED. TEST STRIP LOT# NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT IN (B)(4) 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 2:00 AM, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 260 MG/DL ON THE REPORTED METER, WHICH SHE CLAIMED WAS INACCURATELY HIGH COMPARED TO HER EXPECTED VALUES. BASED ON THIS READING, THE PATIENT TOOK 1.5 UNITS HUMALOG INSULIN VIA THE PUMP. ONE HOUR AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF SWEATING. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING CANDY, AND FELT BETTER AFTERWARDS; SHE DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT MANAGED HER DIABETES WITH INSULIN PUMP THERAPY. TROUBLESHOOTING REVEALED THE PATIENT¿S TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE METER WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS OF SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON AN ELEVATED METER READING, AND RECEIVED TREATMENT WITH FOOD TO ALLEVIATE HER SYMPTOMS. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224759 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R