BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2862929 · Received December 10, 2012

    Report

    Report Number
    2954323-2012-06758
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. NOTE: THE DATE OF THE MEDICAL EVENT IS UNKNOWN, NOTE: THE METER'S MANUFACTURE DATE IS UNKNOWN, (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED METER (B)(4). THE METER WAS INVESTIGATED WITH RETAINED TEST STRIPS. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. GIVEN NO TEST STRIPS WERE RETURNED FOR INVESTIGATION, RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (60023) WERE TESTED WITH CONTROL SOLUTION. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN UNKNOWN READING OBTAINED ON HER ADC METER WAS HIGHER THAN AN UNSPECIFIED READING OBTAINED ON AN UNKNOWN BRAND HCP METER. CUSTOMER FURTHER STATED THAT SHE "FELL IN THE MORNING BUT DOESN'T KNOW WHY". IT WAS FURTHER REPORTED THAT "IT WAS NOT CLARIFIED IF THE READINGS ISSUE CONTRIBUTED TO THE MEDICAL EVENT". MEDICAL SURVEY WAS NOT COMPLETED BECAUSE CUSTOMER DECLINED TO CONTINUE TROUBLESHOOTING. PRIOR TO DISCONNECTING THE PHONE CALL CUSTOMER STATED THAT SHE HAD SUSTAINED AN UNSPECIFIED INJURY. 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 60023

    Patients

    Seq Age Sex Outcome Treatment
    1 Other