BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCELERATE PHENO SYSTEM, ACCELERATE PHENOTEST BC KIT

    MDR report key: 9227519 · Received October 23, 2019

    Report

    Report Number
    3010671651-2019-00001
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    September 19, 2019
    Report Date
    October 23, 2019
    Manufacturer
    ACCELERATE DIAGNOSTICS, INC.
    Product Code
    PRH
    UDI-DI
    00862011000314
    PMA / PMN Number
    DEN160032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCELERATE PHENO¿ SYSTEM IS A FULLY-INTEGRATED IN VITRO DIAGNOSTIC SYSTEM COMPRISED OF ONE TO EIGHT ID/AST MODULE(S), A COMPUTING SYSTEM, TOUCHSCREEN MONITOR AND ACCELERATE PHENO¿ SYSTEM SOFTWARE FOR USE WITH ACCELERATE PHENOTEST¿ KITS. IT IS DESIGNED TO PERFORM IDENTIFICATION (ID) OF BACTERIAL AND YEAST CELLS AND ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST) IN APPROXIMATELY 7 HOURS DIRECTLY FROM POSITIVE BLOOD CULTURE SAMPLES. ACCELERATE DIAGNOSTICS OPENED AN INVESTIGATION AFTER RECEIVING A COMPLAINT. RUN DATA AND IMAGES OBTAINED FROM THE ACCELERATE PHENO¿ SYSTEM RUN IN QUESTION WERE REVIEWED. THE CONCLUSION WAS THAT THE SAMPLE CONTAINED A HIGH AMOUNT OF DEBRIS IN THE PSEUDOMONAS AERUGINOSA (PAE) CHANNEL AND VERY FEW RODS WERE OBSERVED IN THE ESCHERICHIA COLI CHANNEL (BELOW THE LIMIT OF DETECTION). AS PART OF THE INVESTIGATION, THE SAMPLE WAS SENT TO ACCELERATE DIAGNOSTICS, INC. FOR DISCREPANCY TESTING. TESTING WAS COMPLETED USING MALD-TOF, AND RESULTS CONFIRMED THE SAMPLE CONTAINED ESCHERICHIA COLI ONLY. NEGATIVE SAMPLE TESTING WAS ALSO PERFORMED TO DETERMINE IF THE PAE PROBE CONTAINS DEBRIS THAT COULD CAUSE FALSE POSITIVE RESULTS. NEGATIVE SAMPLE TESTING DEMONSTRATED THAT THE PROBE DOES NOT CONTAIN DEBRIS. ROOT CAUSE OF THE FALSE-POSITIVE PAE WAS DETERMINED TO BE DEBRIS IN THE PAE CHANNEL, YET CAUSE OF THE DEBRIS CANNOT BE DETERMINED. FALSE POSITIVES ARE INHERENT TO THE DEVICE AND INCLUDED IN THE LABELING.

    Description of Event or Problem · 1

    THE ACCELERATE PHENO¿ SYSTEM REPORTED PSEUDOMONAS AERUGINOSA (FALSE POSITIVE). THE PATIENT RECEIVED AN ESCALATION OF ANTIBIOTICS, AN ID CONSULT, AND CT CHEST/ABDOMEN/PELVIS TO IDENTIFY THE SOURCE OF THE INFECTION. THE COMPARATOR METHOD (MALDI-TOF) IDENTIFIED ESCHERICHIA COLI. A PATIENT ADMITTED WITH ASCENDING CHOLANGITIS HAD BLOOD CULTURES TAKEN FOR IDENTIFICATION (ID)AND ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST). THE ACCELERATE PHENO¿ SYSTEM ID RESULT INDICATED THAT THE PATIENT WAS INFECTED WITH DRUG-RESISTANT PSEUDOMONAS AERUGINOSA. IN RESPONSE, ANTIBIOTIC TREATMENT WAS ESCALATED USING CEFEPIME, AN ID CONSULT WAS INITIATED, AND THE PATIENT RECEIVED A CT CHEST/ABDOMEN/PELVIS TO IDENTIFY THE SOURCE OF THE PAE INFECTION AND DETERMINE WHETHER IT WAS PRESENT ON THE PATIENT'S SPINAL HARDWARE. AFTER 24 HOURS, COMPARATIVE TEST (MALD-TOF) RESULTS IDENTIFIED THE BACTERIA AS ESCHERICHIA COLI, NOT PSEUDOMONAS AERUGINOSA. PATIENT THERAPY WAS THEN DEESCALATED TO ORAL CIPROFLOXACIN. THE PATIENT RESPONDED WELL AND WAS DISCHARGED ON THE ORAL CIPROFLOXACIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025274 ACCELERATE PHENO SYSTEM, ACCELERATE PHENOTEST BC KIT ACCELERATE PHENO¿ SYSTEM PRH ACCELERATE DIAGNOSTICS, INC. 10401008 3715A 00862011000314

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| O