BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA

    MDR report key: 1873275 · Received October 18, 2010

    Report

    Report Number
    2954323-2010-01446
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 15, 2010
    Report Date
    November 15, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER SN LISTED IN THIS COMPLAINT IS THE CUSTOMER'S METER THAT WAS REQUESTED FOR REPLACEMENT. IF RETURNED, THE ORIGINAL COMPLAINANT PRODUCT WILL BE INVESTIGATED AND A SUPPLEMENTAL REPORT WILL BE SENT ONCE NEW INFORMATION IS OBTAINED. IN ADDITION, THE CUSTOMER WAS PROVIDED A METER KIT THROUGH A SUCCESSFUL FIELD EXCHANGE DURING THE INITIAL CALL.

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER WAS RETURNED AND INVESTIGATED. THE COMPLAINT IS NOT CONFIRMED. THE RETURNED METER POWERED ON WITH BUTTON PRESS AND STRIP INSERTION. CONTROL SOLUTION TESTING WAS PERFORMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. NO NEW ISSUES WERE OBSERVED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    AN ADC CUSTOMER'S WIFE CALLED TO REPORT THAT THE CUSTOMER HAD NOT YET RECEIVED HIS REPLACEMENT METER KIT PREVIOUSLY ORDERED ON 07SEP2010, AND AS A RESULT OF HIS METER "NOT FUNCTIONING" HE EXPERIENCED AN INJURY. SPECIFICALLY, THE CUSTOMER'S WIFE REPORTED THE CUSTOMER EXPERIENCED SYMPTOMS OF "SWEATING, HOT/COLD FLASHES AND ELEVATED BLOOD PRESSURE." THE CUSTOMER REPORTED HE WAS SEEN AT A LOCAL HEALTH CARE FACILITY, DIAGNOSED WITH HYPERGLYCEMIA AND GIVEN INSULIN (ROUTE AND TYPE UNKNOWN). SHIPPING HISTORY FOR THE REPLACEMENT METER INDICATED THAT THE METER KIT WAS DELIVERED TO THE CUSTOMER'S ADDRESS ON FILE ON 09SEP2010; HOWEVER, THE CUSTOMER'S LAST NAME WAS REPORTEDLY INCORRECT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention