BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX

    MDR report key: 6867429 · Received September 14, 2017

    Report

    Report Number
    2024800-2017-00024
    Event Type
    Injury
    Date Received
    September 14, 2017
    Date of Event
    August 18, 2017
    Report Date
    November 28, 2017
    Manufacturer
    HOLOGIC, INC.
    Product Code
    LQF
    UDI-DI
    15420045506169
    PMA / PMN Number
    K896493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL REPORT. THE CUSTOMER SAMPLE WAS SENT TO HOLOGIC FOR TESTING. VISUAL TESTING SHOWED THAT THE SAMPLE HAD A LOWER CONCENTRATION (LESS TURBIDITY) THAN WHAT IS RECOMMENDED IN THE PI (102896-IFU-PI, REV. 001). EXPERIMENTAL TESTING AT HOLOGIC DEMONSTRATED THAT THERE ARE NO INHERENT ISSUES WITH PROBE REAGENT A, M. TUBERCULOSIS (PN: 102688-01, LN: 216901). THE CUSTOMER SAMPLE WAS TESTED IN DUPLICATE AND EACH DUPLICATE HAD RLU > 30,000, INDICATING A POSITIVE RESULT IN ACCUPROBE MTBC CULTURE. THEREFORE, HOLOGIC COULD NOT REPLICATE THE NEGATIVE RESULTS FOR THE CUSTOMER SAMPLE. THE DISCREPANCY BETWEEN HOLOGIC'S RESULTS AND THE CUSTOMER'S RESULTS IS NOT CLEAR. HOWEVER, THE CUSTOMER OBTAINED THE SECOND NEGATIVE RESULT FROM THE SAMPLE ON (B)(6) 2017 AND THE SAMPLE WAS SHIPPED TO HOLOGIC ON 09/07/2017. THEREFORE, SINCE THE CUSTOMER'S STORAGE CONDITION FOR THE SAMPLE WAS NOT INDICATED, IT IS POSSIBLE THAT THE SAMPLE EXHIBITED GROWTH DURING THAT TIME, WHICH MAY HAVE CONTRIBUTED TO THE DISCREPANT RESULTS. FINAL RISK ASSESSMENT INDICATED FALSE NEGATIVE OR INCORRECT RESULT FROM COMPROMISED SAMPLE DURING PREPARATION COULD SERIOUS. THE PROBABILITY OF OBTAINING A FALSE NEGATIVE RESULT IS REMOTE AND CAN BE MITIGATED BY FOLLOWING THE PI INSTRUCTIONS FOR PROPER SAMPLE PREPARATION. THE OVERALL RISK IS AS FAR AS POSSIBLE, AND NO FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER, (B)(6) AT (B)(6), OBTAINED A PATIENT ISOLATE AT THE END OF JULY. THE PATIENT SAMPLE WAS GROWN ON A MYCOBACTERIA GROWTH INDICATOR TUBE (MGIT) AND THE SMEAR WAS ACID-FAST BACILLI (AFB) POSITIVE AND EXHIBITED "DRAGON" CORDING, CONSISTENT WITH MYCOBACTERIUM TUBERCULOSIS COMPLEX (MTBC) MORPHOLOGY. THE CUSTOMER TESTED THE PATIENT SAMPLE USING HOLOGIC'S ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX CULTURE IDENTIFICATION TEST AND TWICE OBTAINED A (B)(6) RESULT. CUSTOMER STATED THEY ARE CONFIDENT THIS PATIENT HAS (B)(6). THE RUN RESULTS WERE REVIEWED BY HOLOGIC, WHICH DEMONSTRATED THAT THE CONTROL VALUES WERE STRONG AND THAT THERE WERE OTHER POSITIVE SAMPLES IN THE RUN OBTAINED BY THE CUSTOMER. THE CUSTOMER RETESTED THE ORIGINAL SPECIMEN USING THE CEPHEID GENEXPERT MTB/RIF ASSAY AND FOUND THE SPECIMEN TO BE MTBC-POSITIVE. THE GENEXPERT MTB/RIF ASSAY IS A NEWER GENERATION SYSTEM THAT USES REAL-TIME POLYMERASE CHAIN REACTION (PCR) TO AMPLIFY THE TARGET DNA STRANDS FOR DETECTION, WHILE THE ACCUPROBE SYSTEM IS A NON-AMPLIFIED DETECTION SYSTEM. COMBINED, THESE DATA SUGGESTS THAT THE ACCUPROBE MTBC TEST POTENTIALLY GAVE A FALSE NEGATIVE RESULT. ADDITIONAL SAMPLES TAKEN FROM THE SAME PATIENT RESULTED IN POSITIVE RESULTS USING THE ACCUPROBE MTBC KIT. PER PRELIMINARY RISK ASSESSMENT, SEVERAL FACTORS THAT MAY CONTRIBUTE TO OBTAINING A FALSE NEGATIVE RESULT USING THE ACCUPROBE MTBC ASSAY. THESE INCLUDE: A MANUFACTURING DEFECT, A COMPROMISED KIT DUE TO STORAGE AT THE CUSTOMER SITE, OR SAMPLES THAT HAVE BEEN IMPROPERLY PREPARED. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS FOR THE SAME LOT IN THE LAST 12 MONTHS. THE ORIGINAL SAMPLE WAS RETURNED TO HOLOGIC AND WILL BE INVESTIGATED UNDER (B)(4). A FINAL RISK ASSESSMENT WILL BE PERFORMED FOLLOWING THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647501 ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX IN-VITRO DIAGNOSTICS LQF HOLOGIC, INC. 216323H 15420045506169

    Patients

    Seq Age Sex Outcome Treatment
    1 Other