BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO SYNC METER

    MDR report key: 3460942 · Received November 12, 2013

    Report

    Report Number
    2939301-2013-07779
    Event Type
    Injury
    Date Received
    November 12, 2013
    Report Date
    October 25, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K120708
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH VERIO SYNC METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT 551AM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF ¿75 MG/DL¿ WITH THE SUBJECT METER AND ¿59 MG/DL¿ ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DO NOT EXCEED THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. IT IS NOT KNOWN HOW THE PATIENT MANAGES HER DIABETES OR IF CHANGES WERE MADE TO HER USUAL MANAGEMENT ROUTINE. THE PATIENT CLAIMED SHE FELT A SYMPTOM OF SHAKY WHICH CORRELATED WITH THE RESULT OBTAINED WITH THE OTHER DEVICE. TREATMENT WAS NOT SPECIFIED. THE PATIENT ALSO PROVIDED ADDITIONAL RESULTS OF ¿181, 234 AND 174 MG/DL¿ WITH THE SUBJECT METER AND ¿143, 174 AND 147 MG/DL¿ WITH THE OTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER, RESPECTIVELY. 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 FOR QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY; HOWEVER, IT IS NOT CLEAR WHAT MAY HAVE CAUSED OR CONTRIBUTED TO HER REPORTED SYMPTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582698 OT VERIO SYNC METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3496769

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R