BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2200373 · Received August 11, 2011

    Report

    Report Number
    2954323-2011-04156
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 21, 2011
    Report Date
    September 9, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DATE OF EVENT IS UNKNOWN. THE DATE LISTED IN SECTION B-3 IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE RECEIVED A READING OF 246 MG/DL ON (B)(6) 2011, 196 MG/DL ON (B)(6) 2011, AND 259 MG/DL ON (B)(6) 2011, ON HIS ADC BLOOD GLUCOSE METER, WHICH WAS HIGHER THAN HE FELT. IN ADDITION, CUSTOMER REPORTED THAT ON TWO OCCASIONS (UNKNOWN DATES) HE TOOK INSULIN BASED ON THE READINGS HE OBTAINED AND SUBSEQUENTLY EXPERIENCING WEAKNESS AND LOST CONSCIOUSNESS. NO THIRD-PARTY MEDICAL INTERVENTION WAS REPORTED. CUSTOMER SELF-TREATED BY DRINKING JUICE AND EATING COOKIES AND SUGARY PRODUCTS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001A577

    Patients

    Seq Age Sex Outcome Treatment
    1 Other