BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3072825 · Received April 23, 2013

    Report

    Report Number
    3008382007-2013-08723
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 2, 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
    NC, 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 (LFS) ALLEGING THAT HIS ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH COMPARED TO HIS FREESTYLE METER. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2013, AT 6PM. THE PATIENT CLAIMED THE SUBJECT METER WAS READING "30 POINTS" HIGHER THAN THE FREESTYLE METER (BLOOD GLUCOSE READINGS WITH BOTH METERS ARE NOT SPECIFIED), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT MANAGES HIS DIABETES WITH 1000MG OF METFORMIN (TWICE A DAY) AND 25 UNITS OF NOVOLOG (TWICE A DAY). IN RESPONSE TO THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY CONTINUED WITH HIS USUAL DOSE OF MEDICATION (TIME NOT SPECIFIED). ACCORDING TO THE CSR'S DOCUMENTATION, AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF HUNGER, SWEATING, AND SHAKING TWO HOURS LATER (8PM), AND AT THE ONSET OF HIS SYMPTOM THE PATIENT REPORTEDLY FOOD AND/OR DRINK AS SELF-TREATMENT. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING, AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S BOOKLET) SAMPLE SITE. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175592 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3318430

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| R