BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 4112505 · Received September 24, 2014

    Report

    Report Number
    2939301-2014-25242
    Event Type
    Injury
    Date Received
    September 24, 2014
    Report Date
    September 16, 2014
    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
    LA, 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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING MULTIPLE INACCURACY COMPLAINTS AGAINST HER ONETOUCH VERIOIQ METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT INDICATED THAT SHE FIRST NOTICED A PROBLEM WITH THE SUBJECT METER ON (B)(6) 2014, AT 4:12PM CST. SHE REPORTED OBTAINING, ON DATES/TIMES UNSPECIFIED, THE FOLLOWING BLOOD GLUCOSE RESULTS: ¿205, 153, 137, 189 AND 179 MG/DL¿ OBTAINED ON THE SUBJECT METER WITHIN 20 MINUTES OF EACH OTHER; ¿300 MG/DL¿ ON THE SUBJECT METER COMPARED TO ¿145 MG/DL¿ ON AN ACCU-CHEK METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER; AND ¿245 MG/DL¿ ON THE SUBJECT METER COMPARED TO ¿140 MG/DL¿ ON AN UNSPECIFIED BACKUP METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE RESULTS FALLS OUTSIDE LFS¿ ACCURACY/PRECISION CRITERIA. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF-ADJUSTER). IT IS UNKNOWN WHETHER THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF RECEIVING THE ALLEGED INACCURATE RESULTS. SHE ALLEGED, ON DATE/TIME UNKNOWN, AFTER THE ISSUE WITH THE METER STARTED, DEVELOPING SYMPTOMS OF ¿SHAKY, SWEATY, HEADACHE¿. SHE DENIED RECEIVING ANY TREATMENT FOR HER ALLEGED SYMPTOMS. DURING TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT HAD BEEN STORING HER TEST STRIPS CORRECTLY, THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN AND THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE CCA ALSO NOTED THAT HE PATIENT WAS USING THE CORRECT TESTING PROCEDURE. HOWEVER, SHE DID NOT HAVE CONTROL SOLUTION WITH WHICH TO TEST THE METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMED SHE OBTAINED INACCURATE READINGS ON THE SUBJECT METER, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593373 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3671117

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening