BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2073399 · Received May 1, 2011

    Report

    Report Number
    2954323-2011-03106
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    April 1, 2011
    Report Date
    June 28, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (45001E037) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER CALLED ADC AND STATED "MY HEALTH HAS BEEN DAMAGED DUE TO YOUR NEGLIGENCE (AND) THAT HIS HEALTH WAS ADVERSELY AFFECTED BY OUR METERS. " THE CUSTOMER FURTHER REPORTED HIS PRECISION XTRA METER WAS GIVING FALSE READINGS AND THEN STATED HIS HEALTH WAS AFFECTED BECAUSE HE COULD NOT TEST. HE STATED THAT HIS BLOOD SUGARS WERE OVER 400. THE READINGS HE WAS GETTING ON THEIR PRECISION XTRA METER WERE LOWER WHEN COMPARED TO ANOTHER METER. THE CUSTOMER BECAME VERY AGITATED WHEN CUSTOMER SERVICE AGENT ATTEMPTED TO TROUBLESHOOT THE READINGS ISSUE AND REFUSED TO ANSWER ANY MORE QUESTIONS. THE CUSTOMER STATED THAT HE HAS 3 METERS THAT DO NOT WORK DUE TO MOISTURE. HE STATED THAT THE METERS WERE "SITTING ON THE DEHUMIDIFIER", THE BATTERY COMPARTMENT GOT MOISTURE IN IT AND THE METERS STOPPED WORKING. 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 45001E037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other