BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3171493 · Received June 15, 2013

    Report

    Report Number
    3008382007-2013-17402
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    June 12, 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
    NY, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (07/05/2013).THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 6/20/2013 AND 6/27/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE RESULTS. THE PATIENT RECEIVED A RESULT OF "199MG/DL" ON A LIFESCAN METER AND 137MG/DL ON ANOTHER METER WITHIN 30 MINUTES OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% FOR READINGS ABOVE 75MG/DL TAKEN WITHIN 30 MINUTES OF ONE ANOTHER. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS OR TREATMENT SUGGESTIVE THAT AN ACUTE COMPLICATION OF DIABETES OCCURRED. IN ADDITION THE PATIENT MADE A METER VS. METER COMPARISON WHICH FALLS WITHIN LFS' ACCEPTABLE ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272663 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3423684

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR