BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD COR¿ GX

    MDR report key: 14061449 · Received April 8, 2022

    Report

    Report Number
    1119779-2022-00546
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 7, 2022
    Report Date
    June 10, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MAQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY HE COMPLAINT OF UPC-4 PIPETTOR DRIPPING WAS REPORTED AGAINST THE BD COR GX INSTRUMENT CATALOG NUMBER 443990, SERIAL NUMBER (B)(6). THE COMPLAINT IS CONFIRMED. VIDEO FROM THE GX INSTRUMENT WAS REVIEWED AND DRIPS WERE IDENTIFIED FROM UPC-4. SERVICE WAS DISPATCHED. THE DECK WAS CLEANED AND THE PRESSURE AND VACUUM LINES FROM THE PRESSURECONTROLLER TO THE PIPETTES WERE CHECKED FOR DAMAGE. NO DAMAGE WAS IDENTIFIED. SERVICE REPLACED PIPETTE CHANNEL INLINE UPC SPARES UPC-3 AND UPC-4 (PART NUMBER 444071). THE INSTRUMENT WAS TESTED AND IS FUNCTIONING. THE SERVICE HISTORY OF THE INSTRUMENT WAS REVIEWED, NO ADDITIONAL OR PREVIOUS DRIPPING COMPLAINTS OR CONTAMINATION COMPLAINTS WERE RECEIVED. THE INSTRUMENT IS DESIGNED TO AVOID MOVEMENT OVER OPEN SAMPLES TO MINIMIZE THE RISK OF CONTAMINATION. THE ROOT CAUSE IS ASSOCIATED WITH THE UPC. THE UPC WAS NOT RETURNED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD COR¿ GX THE CUSTOMER OBSERVED AN INSTRUMENT ERROR THAT MAY HAVE RESULT IN CROSS-CONTAMINATION AND ULTIMATELY ERRONEOUS RESULTS. THIS EVENT OCCURRED 1 TIME(S). THESE POTENTIALLY ERRONEOUS RESULTS MAY HAVE BEEN REPORTED TO HEALTH CARE PRACTITIONERS. AT THIS TIME THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT CANNOT BE EXCLUDED THAT THIS ISSUE HAS LED TO ERRONEOUS RESULTS, BECAUSE THIS ISSUE HAS BEEN ONGOING FOR APPROXIMATELY 7 DAYS, AND IN THIS TIME, 780 RESULTS WERE SENT TO THE CUSTOMERS LIS SYSTEM, IT CAN ALSO NOT BE EXCLUDED THAT ERRONEOUS RESULTS WERE REPORTED TO THE CLINICIAN. AS IN THESE 780 RESULTS, 173 RESULTS WERE HPV POSITIVE, IT CANNOT BE EXCLUDED THAT PATIENTS WERE TREATED BASED ON ERRONEOUS RESULTS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD COR¿ GX THE CUSTOMER OBSERVED AN INSTRUMENT ERROR THAT MAY HAVE RESULT IN CROSS-CONTAMINATION AND ULTIMATELY ERRONEOUS RESULTS. THIS EVENT OCCURRED 1 TIME(S). THESE POTENTIALLY ERRONEOUS RESULTS MAY HAVE BEEN REPORTED TO HEALTH CARE PRACTITIONERS. AT THIS TIME THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT CANNOT BE EXCLUDED THAT THIS ISSUE HAS LED TO ERRONEOUS RESULTS.", "BECAUSE THIS ISSUE HAS BEEN ONGOING FOR APPROXIMATELY 7 DAYS, AND IN THIS TIME, 780 RESULTS WERE SENT TO THE CUSTOMERS LIS SYSTEM, IT CAN ALSO NOT BE EXCLUDED THAT ERRONEOUS RESULTS WERE REPORTED TO THE CLINICIAN.", "AS IN THESE 780 RESULTS, 173 RESULTS WERE HPV POSITIVE, IT CANNOT BE EXCLUDED THAT PATIENTS WERE TREATED BASED ON ERRONEOUS RESULTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2474341 BD COR¿ GX NA MAQ BECTON, DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown