BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 3093142 · Received May 3, 2013

    Report

    Report Number
    3008382007-2013-10201
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 16, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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 HIS ONETOUCH VERIOPRO METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN IN (B)(6) 2013. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS AROUND "3.9 MMOL/L TO 20 MMOL/L" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE RESULTS FELL OUTSIDE EXPECTED VALUES FOR PRECISION TESTING. IT IS NOT KNOWN HOW THE PATIENT MANAGES HIS DIABETES OR IF CHANGES WERE MADE TO HIS USUAL MANAGEMENT ROUTINE. PRIOR TO TESTING, WHEN HIS BLOOD GLUCOSE READS LOW, THE PATIENT CLAIMS HE FEELS A SYMPTOM OF "PRICKLY FINGERS" (ESPECIALLY IN THE LEFT HAND). THE PATIENT ATTRIBUTES HIS LOWER READINGS TO NOT EATING PROPERLY AND NOT TESTING REGULARLY. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT DUE TO THE REPORTED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S REPORTED SYMPTOM OF "PRICKLY FINGERS" DOES NOT MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY. THE PATIENT ALSO DENIED RECEIVING TREATMENT AS A RESULT OF THE ALLEGED ISSUE. 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
    194031 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR