BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1850705 · Received October 1, 2010

    Report

    Report Number
    2954323-2010-01365
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 12, 2010
    Report Date
    October 1, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THIS CASE DOES NOT INVOLVE A PRODUCT MALFUNCTION. SINCE THE MEDICAL EVENT WAS RELATED TO A TRAINING ISSUE, NO INVESTIGATION OF THE PRODUCT IS REQUIRED. MULTIPLE ATTEMPTS HAD BEEN MADE TO OBTAIN MISSING INFORMATION WITHOUT SUCCESS.

    Description of Event or Problem · 1

    A CUSTOMER'S WIFE CALLED IN REQUESTING TRAINING ON HOW TO CONDUCT FINGER STICK TEST AS SHE TRIED TO CHECK CUSTOMER'S BLOOD SUGAR WHILE HE WAS "GOING IN AND OUT OF CONSCIOUSNESS." ADDITIONALLY, THE STRIP LOT OF THE TEST STRIPS THE CALLER TRIED TO USE DID NOT MATCH THE CALIBRATION NUMBER IN THE METER. THE CALLER FURTHER STATED THAT SHE HAD TO TAKE HER HUSBAND TO A HOSPITAL AND COULDN'T FINISH TROUBLESHOOTING AND PROVIDE ANY ADDITIONAL INFORMATION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001A647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other