BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA

    MDR report key: 1884385 · Received October 27, 2010

    Report

    Report Number
    2954323-2010-01491
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    May 15, 2006
    Report Date
    November 9, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER (B)(4) WAS RETURNED AND INVESTIGATED. THE COMPLAINT IS CONFIRMED. UNIT OF MEASURE FOR RETURNED METER WAS SET AND LOCKED IN MG/DL WHEN RECEIVED. THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DEVICE MANUFACTURE DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: THE XCEED METER SN# (B)(4) WAS CONFIRMED TO HAVE THE INCORRECT UNIT OF MEASUREMENT (UOM) LOCKED (MG/DL INSTEAD OF MMOL/L). THE PROBLEM WAS FOUND TO BE INCORRECT SETTINGS IN THE OPTION BLOCK. A QUALITY CHECK WAS ADDED IN THE MANUFACTURING PROCESS TO VERIFY THAT THE METER UNIT OF MEASURE WAS PROGRAMMED CORRECTLY. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATIONS RESULTS: THE XCEED METER WITH S/N (B)(4) WAS CONFIRMED TO HAVE THE INCORRECT UNIT OF MEASUREMENT (UOM) LOCKED (MG/DL INSTEAD OF MMOL/L). THE PROBLEM WAS FOUND TO BE INCORRECT SETTINGS IN THE OPTION BLOCK. A QUALITY CHECK WAS ADDED IN MANUFACTURING PROCESS TO VERIFY THAT THE METER UNIT OF MEASURE WAS PROGRAMMED CORRECTLY. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THERE WAS A BAD STAPLE LINE AFTER FIRING THE DEVICE, THERE WERE MALFORMED STAPLES. OVER SEWING WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    AN ADC CUSTOMER CALLED REPORTING RECEIVING A ERROR 6 MESSAGE ON THEIR PRECISION XCEED METER AND WAS NOT ABLE TO TEST. DURING TROUBLESHOOTING WITH ADC CUSTOMER SERVICE OVER THE PHONE, THEY NOTICED THAT METER WAS PRE-SET IN MG/DL. THERE WAS NO REPORT OF SERIOUS INJURY, DEATH OR MISTREATMENT ASSOCIATED WITH THIS COMPLAINT. THE METER WAS RETURNED TO ADC AND UPON INITIAL INVESTIGATION IT WAS NOTED THAT THE DATE AND TIME WERE CORRECT HOWEVER, THE UNITS OF MEASURE HAD INADVERTENTLY CHANGED FROM MMOL/L TO MG/DL. THIS COMPLAINT WAS IDENTIFIED AS PART OF A COMPLAINT REVIEW BASED ON A CONFIRMED COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ELC PROCEDURE, THE DEVICE WOULD NOT OPEN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT IMPACT WAS REPORTED. NO OTHER DETAILS OF THE EVENT ARE KNOWN.

    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