BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MYCOPREP¿ SPECIMEN DIGESTION/DECONTAMINATION KIT, 150ML

    MDR report key: 12620979 · Received October 13, 2021

    Report

    Report Number
    1119779-2021-01640
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    September 13, 2021
    Report Date
    March 23, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LDT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS MEMO SERVES TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT (B)(4) ON PRODUCT 240863 (KIT MYCOPREP 150ML), LOT NUMBER 452120, WHERE IT WAS OBSERVED THAT THE PH OF THE SOLUTION WITH BUFFER WAS ALKALINE. EVENT DESCRIPTION: "ALKALINE PH DETECTED (INSTEAD OF NEUTRAL PH) AFTER INCLUDING PHOSPHATE BUFFER AND ALSO AFTER CENTRIFUGATION.¿ COMPLAINT HISTORY REVIEW: A REVIEW OF PAST COMPLAINTS ON THIS PRODUCT OVER THE PAST 12 MONTHS DOES NOT INDICATE A TREND ON THIS ISSUE. DEVICE HISTORY RECORD REVIEW: THE REVIEW OF THE DEVICE HISTORY RECORD DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY AND NO DEVIATIONS WERE NOTED. SAMPLE ANALYSIS: THE PHOTO THAT WAS SENT DID NOT CLEARLY SHOW THE NOTED DEFECT. NO RETURNS WERE AVAILABLE. AN INSPECTION OF THE RETENTION SAMPLES WAS SATISFACTORY. EVALUATIONS RESULTS: BASED ON THE INVESTIGATION, THE COMPLAINT WAS NOT CONFIRMED ON THE PHOTO. THERE IS NO SYSTEMIC FAILURE IN THE MANUFACTURING PROCESS AND THE RETENTION SAMPLES WERE SATISFACTORY. AS NO DEVIATIONS WERE OBSERVED IN THE INVESTIGATION, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE INDICATED AT THIS TIME. HOWEVER, BD WILL CONTINUE TO MONITOR FOR TRENDING. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE INVESTIGATION, THE COMPLAINT WAS NOT CONFIRMED. NO FURTHER ACTIONS WILL BE TAKEN AS NO CONFIRMED TREND HAS BEEN IDENTIFIED. BD WILL CONTINUE TO MONITOR FOR TRENDING.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH BD MYCOPREP¿ SPECIMEN DIGESTION/DECONTAMINATION KIT, 150ML ATYPICAL RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALKALINE PH DETECTED (INSTEAD OF NEUTRAL PH) AFTER INCLUDING PHOSPHATE BUFFER AND ALSO AFTER CENTRIFUGATION . NEUTRAL PH IS ACHIEVED WHEN THE SAMPLE IS INCLUDED IN THE BOTTLE. IF THERE WERE PATIENT SAMPLES, WERE INCORRECT RESULTS OBTAINED OR USED? IT IS BEING USED WITH ALL PATIENT SAMPLES. IT IS IMPOSSIBLE TO KNOW IF THE CULTURE IS NEGATIVE DUE TO EXCESS ACTION OF THE NAOH OR BECAUSE IT IS REALLY NEGATIVE. RIGHT NOW WE HAVE TWO PATIENTS WITH POSITIVE SMEAR MICROSCOPY, WE WILL SEE WHAT THE RESULT IS LIKE, BUT IN THOSE WHOSE SMEAR MICROSCOPY IS NEGATIVE, WE CANNOT KNOW IF THE RESULT IS INCORRECT. HAS ANY TREATMENT BEEN GIVEN TO THE PATIENT BASED ON THE OUTCOME? WHAT THIS INCIDENT MAKES IS TO DOUBT IF THE CULTURES BECOME NEGATIVE DUE TO EXCESS PERFORMANCE OF THE MYCOPREP, NOT BECAUSE THEY GIVE US POSITIVE RESULTS THAT WOULD INDICATE A TREATMENT. HAS THERE BEEN DANGER TO THE PATIENT? WELL, IF TUBERCULOSIS OR MYCOBACTERIOSIS IS NOT DIAGNOSED, YES THERE IS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH BD MYCOPREP¿ SPECIMEN DIGESTION/DECONTAMINATION KIT, 150ML ATYPICAL RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALKALINE PH DETECTED (INSTEAD OF NEUTRAL PH) AFTER INCLUDING PHOSPHATE BUFFER AND ALSO AFTER CENTRIFUGATION. NEUTRAL PH IS ACHIEVED WHEN THE SAMPLE IS INCLUDED IN THE BOTTLE. IF THERE WERE PATIENT SAMPLES, WERE INCORRECT RESULTS OBTAINED OR USED? IT IS BEING USED WITH ALL PATIENT SAMPLES. IT IS IMPOSSIBLE TO KNOW IF THE CULTURE IS NEGATIVE DUE TO EXCESS ACTION OF THE (B)(4) OR BECAUSE IT IS REALLY NEGATIVE. RIGHT NOW WE HAVE TWO PATIENTS WITH POSITIVE SMEAR MICROSCOPY, WE WILL SEE WHAT THE RESULT IS LIKE, BUT IN THOSE WHOSE SMEAR MICROSCOPY IS NEGATIVE, WE CANNOT KNOW IF THE RESULT IS INCORRECT. HAS ANY TREATMENT BEEN GIVEN TO THE PATIENT BASED ON THE OUTCOME? WHAT THIS INCIDENT MAKES IS TO DOUBT IF THE CULTURES BECOME NEGATIVE DUE TO EXCESS PERFORMANCE OF THE MYCOPREP, NOT BECAUSE THEY GIVE US POSITIVE RESULTS THAT WOULD INDICATE A TREATMENT. HAS THERE BEEN DANGER TO THE PATIENT? WELL, IF TUBERCULOSIS OR MYCOBACTERIOSIS IS NOT DIAGNOSED, YES THERE IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519473 BD MYCOPREP¿ SPECIMEN DIGESTION/DECONTAMINATION KIT, 150ML REAGENT, GENERAL PURPOSE LDT BECTON, DICKINSON & CO. (SPARKS) 452120

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown