BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA

    MDR report key: 1860313 · Received October 7, 2010

    Report

    Report Number
    2954323-2010-01378
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 21, 2010
    Report Date
    November 8, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER HAS BEEN RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READINGS THE CUSTOMER REPORTED WERE FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING A CHECK LINES & BAGS ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING PRIME (PATIENT NOT CONNECTED), THE HOME PATIENT (HP) REVEALED THAT HE ACCIDENTLY PULLED-OUT THE HEATER LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT SUPPLIES WERE THEN COMPROMISED AND ADVISED HP TO START OVER WITH NEW SUPPLIES. THE HP UNDERSTOOD EXPLANATION AND WOULD START OVER WITH NEW SUPPLIES. DURING A FOLLOW UP WITH THE HP REGARDING PULLING-OUT THE HEATER LINE, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED, AND HE HAD RESUMED THERAPY. THE HP CONFIRMED THAT THERE WERE NO DEFECTS ON THE SUPPLIES. THE HP VERIFIED THAT HE HAD ACCIDENTALLY PULLED THE TUBING OUT. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR PRECISION XTRA METER. CUSTOMER REPORTED RECEIVING READINGS OF 49 MG/DL, 325 MG/DL, 125 MG/DL, 69 MG/DL AND 200 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 44288

    Patients

    Seq Age Sex Outcome Treatment
    1