BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 3062244 · Received April 16, 2013

    Report

    Report Number
    2954323-2013-00231
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 27, 2013
    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. THE SERIAL NUMBER OF THE METER IS UNKNOWN. THEREFORE, THE DATE OF MANUFACTURE IS UNKNOWN. THE DATE LISTED, IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A CALLER, CALLING ON BEHALF OF A CUSTOMER, REPORTED THE CUSTOMER'S ADC BLOOD GLUCOSE METER WOULD NOT TURN ON WHEN THE BUTTON WAS PRESSED OR WITH TEST STRIP INSERTION. CALLER FURTHER REPORTED THAT ON (B)(6) 2013, CUSTOMER EXPERIENCED DIZZINESS, FEELING TIRED AND WAS VOMITING. CALLER ALSO NOTED THAT FOR APPROXIMATELY 20 DAYS PRIOR TO CALLING, THE CUSTOMER NOTED A WOUND ("PIMPLE") ON HIS FOOT THAT WAS GETTING LARGER. CUSTOMER SELF-PRESENTED TO A LOCAL HEALTHCARE FACILITY WHERE A READING OF GREATER THAN 400 MG/DL WAS RECEIVED. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH AN UNSPECIFIED AMOUNT OF INSULIN. CUSTOMER ALSO HAD HIS FOOT WOUND CLEANSED AND RECEIVED ZOSYN (PIPERACILLIN/TAZOBACTAM) AN ANTIBIOTIC, VIA INTRAVENOUS INFUSION. CUSTOMER DENIED SELF-TREATING. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162212 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R