BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED

    MDR report key: 11344336 · Received February 18, 2021

    Report

    Report Number
    1119779-2021-00325
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 26, 2021
    Report Date
    November 24, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904413859
    PMA / PMN Number
    K915796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: CUSTOMER REPORTED FALSE POSITIVE ISSUE ON A BD BACTEC FX TOP INSTRUMENT (P/N 441385, S/N (B)(6)). NO ERRONEOUS RESULTS WERE REPORTED TO DOCTORS, AND PATIENTS WERE NOT IMPACTED. CUSTOMER INDICATED THAT INSTRUMENT REFLECTS FALSE POSITIVES. BD REMOTE ASSISTANCE COMMUNICATED WITH THE CUSTOMER AND IDENTIFIED ONSITE POWER FAILURE AND DRAWER A/B OFFLINE. BD FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND DISCOVERED INTERMITTENT FALSE POSITIVE CASES. THE FSE INSTALLED ELECTRICAL NETWORK ANALYZER AND SUGGESTED THE CUSTOMER TO INJECT 3ML OF SALINE SOLUTION, OR SOME OTHER COLORED LIQUID INTO A NEW BOTTLE AND LEAVE THAT BOTTLE TO VISUALLY COMPARE WITH THE VOLUME OF THE BOTTLES THAT ARRIVE TO BE INCUBATED IN THE EQUIPMENT. THIS IS A CONFIRMED FAILURE OF THE BD PRODUCT. REVIEW OF THE DEVICE HISTORY RECORD IS NOT REQUIRED DUE TO THE AGE OF THE INSTRUMENT. SERVICE HISTORY RECORD REVIEW REVEALED NO PREVIOUS COMPLAINTS FOR THIS ISSUE. BD QUALITY DID NOT RECEIVE ANY RETURNED PARTS OR INSTRUMENT FOR INVESTIGATION. THE ROOT CAUSE WAS ONSITE POWER FAILURE AND DRAWER A/B OFFLINE. NO NEW TRENDS, RISKS, OR HAZARDS WERE IDENTIFIED AS A RESULT OF THE COMPLAINT. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED 7 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY SOWING AND BACTERIOSCOPY WAS PERFORMED. RESULTS HAVE NOT BEEN REPORTED AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED 7 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY SOWING AND BACTERIOSCOPY WAS PERFORMED. RESULTS HAVE NOT BEEN REPORTED AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239149 BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441385 NA 00382904413859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown