BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2379908 · Received December 16, 2011

    Report

    Report Number
    3008382007-2011-01046
    Event Type
    Malfunction
    Date Received
    December 16, 2011
    Report Date
    November 22, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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) 2011, THE REPORTER CONTACTED LIFESCAN (B)(64) ALLEGING THAT THE SUBJECT METER WAS GIVING INACCURATE METER READINGS COMPARED TO ANOTHER METER. THE PATIENT GOT METER READINGS RANGING FROM 189-279 MG/DL WITH THE SUBJECT METER AND COMPARED IT TO ANOTHER METER THAT READ 141-161 MG/DL: RESULTS WERE OBTAINED WITHIN 30 MINUTES OF EACH OTHER. THE REPORTED RESULTS DO NOT MEET LIFESCAN'S ACCURACY CRITERIA AND THE REPORTED ISSUE WAS UNRESOLVED WITH TROUBLESHOOTING WITH CUSTOMER SERVICE. THERE WERE NO ALLEGATIONS OF HARM OF INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3207679

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR