BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3033391 · Received April 3, 2013

    Report

    Report Number
    3008382007-2013-06886
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 26, 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
    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. WEIGHT: (B)(6).

    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 ERRATIC READINGS. THE TECHNICAL SERVICE REPRESENTATIVE CONTACTED THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER, WAS NOT ABLE TO REACH THE PATIENT BY TELEPHONE. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON THE MORNING (B)(6) 2013 THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 345 MG/DL AND 245 MG/DL ON THE REPORTED METER WITHIN 20 MINUTES OF EACH OTHER. AFTER THESE READINGS, THE PATIENT TOOK 3.0 UNITS NOVORAPID INSULIN AND AN UNSPECIFIED DOSE OF LANTUS INSULIN. AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF SWEATING. THE PATIENT DID NOT REPORT SEEKING ANY MEDICAL ATTENTION OR TREATMENT. THE PATIENT MANAGES HIS DIABETES WITH INSULIN TAKEN ON A SLIDING SCALE. IT WOULD HAVE BEEN HELPFUL TO DETERMINE THE PATIENT'S EXPECTED BLOOD GLUCOSE READINGS, IF SWEATING WAS THE PATIENT'S SYMPTOM OF HYPOGLYCEMIA, THE PATIENT'S READINGS EARLIER ON THE DAY OF THIS EVENT, AND IF HE RECEIVED ANY TREATMENT. TROUBLESHOOTING REVEALED THE PATIENT'S TESTING TECHNIQUE WAS CORRECT, AND THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON ELEVATED METER READINGS, THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137054 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3398899

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening