BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 4481836 · Received February 4, 2015

    Report

    Report Number
    2939301-2015-04258
    Event Type
    Injury
    Date Received
    February 4, 2015
    Report Date
    January 30, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 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) 2015, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH VERIOIQ METER WAS READING INACCURATELY HIGH IN COMPARISON TO HIS FEELINGS OR NORMAL RESULTS. THE PATIENT ALSO CLAIMED THAT BLOOD SAMPLES WERE READING AS CONTROL SOLUTION WHEN TESTING ON THE SUBJECT METER. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT ON DECEMBER 28, 2014, HE OBTAINED RESULTS OF ¿121, 162, 167 AND 289MG/DL¿ ON THE SUBJECT METER. THE PATIENT DETAILED THAT HE MANAGES HIS DIABETES BY SELF-ADJUSTING HIS INSULIN DOSES AND MADE NO CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT ¿30 MINUTES¿ AFTER THE ALLEGED ISSUE HE DEVELOPED SYMPTOMS OF ¿SWEATING PROFUSELY AND LOST CONSCIOUSNESS¿ AND THAT ON (B)(6) 2014, THE EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED, WHO PERFORMED A BLOOD GLUCOSE TEST USING AN EMS METER WHICH GAVE A RESULT OF ¿25MG/DL¿ AND THAT HE WAS TREATED WITH A GLUCAGON INJECTION. DURING TROUBLESHOOTING THE CCA NOTED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND WHEN A CONTROL SOLUTION TEST WAS PERFORMED, THE RESULTS WERE IN RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS HYPOGLYCEMIC EVENT AND RECEIVED MEDICAL INTERVENTION FROM A HEALTHCARE PROFESSIONAL, AFTER THE ALLEGED METER INACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79770 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3604628

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R