BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3253493 · Received July 30, 2013

    Report

    Report Number
    3008382007-2013-21419
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Report Date
    July 19, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH VERIOIQ METER READ INACCURATELY HIGH COMPARED TO THREE OTHER METERS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION, SINCE THE PATIENT DECLINED TO ANSWER ADDITIONAL QUESTIONS DURING A FOLLOW-UP CALL. ON AN UNSPECIFIED DATE/TIME, THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿158 MG/DL¿ WITH THE SUBJECT METER AND RESULTS OF ¿70 MG/DL¿ WITH THREE OTHER METERS (BRANDS OF METERS NOT PROVIDED). THE CSR WAS UNABLE TO CONFIRM HOW MUCH TIME ELAPSED BETWEEN WHEN SHE TESTED WITH THE SUBJECT METER AND WHEN SHE TESTED ON THE OTHER DEVICES. ASSUMING, THE BLOOD GLUCOSE TESTS WERE PERFORMED WITHIN 30 MINUTES OF EACH OTHER, BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30 MG/DL. IT IS NOT KNOWN WHAT MEDICATIONS THE PATIENT TAKES TO MANAGE HER DIABETES. IT IS ALSO NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO AN ALLEGED INACCURATE READING OBTAINED WITH THE SUBJECT METER. AT THE TIME OF THE CALL THE PATIENT REPORTED WHEN SHE OBTAINED THE ALLEGED INACCURATE HIGH RESULT OF ¿158 MG/DL¿ SHE WAS ¿UNDERSUGAR¿. THE SPECIFIC SYMPTOM(S) THE PATIENT WAS EXPERIENCING WAS/WERE NOT PROVIDED. IT IS ALSO NOT KNOWN WHAT TREATMENT, IF ANY, SHE RECEIVED WHEN SHE WAS ¿UNDERSUGAR¿. AT THE TIME OF THE CALL TO LFS, THE PATIENT MENTIONED SHE WAS UNDERGOING LASER TREATMENT FOR HER EYES AS A RESULT OF ¿MALFUNCTIONING LIFESCAN METERS¿. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT DID NOT HAVE THE SUBJECT METER OR TESTING SUPPLIES AVAILABLE FOR REVIEW. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. AS ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED AND/OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT WAS ALREADY SYMPTOMATIC WHEN SHE TESTED WITH THE SUBJECT METER AND OBTAINED ALLEGED INACCURATE HIGH RESULT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS¿ ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355768 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR