BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA INOQULA

    MDR report key: 17278430 · Received July 7, 2023

    Report

    Report Number
    3010141591-2023-00003
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 6, 2023
    Report Date
    July 11, 2023
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTC
    UDI-DI
    00382904472023
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL ADDRESS: (B)(6) H.6. INVESTIGATION SUMMARY: THE CUSTOMER REPORTED ON THE BD KIESTRA INOQULA MATERIAL NUMBER: 447202 SERIAL NUMBER: (B)(6). IT WAS REPORTED BY THE CUSTOMER THAT THERE IS RANDOM NO GROWING IN SOME INOCULATED DISHES. A FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND FOUND THAT THE PDV SENSOR WAS FAULTY. THIS CONFIRMED THE COMPLAINT. LATER, THE FSE WAS PERFORMED THE ACTIVITIES FOR RESOLVING THE ISSUE SUCH AS CHECKING THE OPERATION OF PDV SENSOR, CLEANING, PERFORMING FUNCTIONAL TESTS AND REPLACING WITH A NEW PDV SENSOR. AFTER THIS, THE ISSUE HAS BEEN RESOLVED AND NOW THE INSTRUMENT IS BACK TO ROUTINE USE. NO NEW TRENDS, RISKS, OR HAZARDS WERE IDENTIFIED AS A RESULT OF THIS COMPLAINT. THE ISSUE IN THIS COMPLAINT DOES NOT REQUIRE THE INITIATION OF A CORRECTIVE AND PREVENTATIVE ACTION (CAPA). DEVICE HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED FOR THIS COMPLAINT. THE COMPLAINT WAS EVALUATED VIA OTHER ELEMENTS OF THE INVESTIGATION. THE RESULTS OF THIS EVALUATION HAVE NOT IDENTIFIED ANY NEW HAZARDS, NEW RISKS, OR SPECIFIC TRENDS. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS ISSUE. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THE MDR MFR. # 3010141591-2023-00003 WAS SENT IN ERROR. REVIEW OF THE EVENT WITH THE SUBJECT MATTER EXPERTS IN THE BUSINESS UNIT INDICATE THAT THIS WAS A "NO INOCULATION" EVENT AND AS SUCH IS NOT REPORTABLE. THE RECORD SHOULD BE CONSIDERED CANCELED.SEE H. 10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD KIESTRA INOQULA OBTAINED A FALSE NEGATIVE RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RANDOM NO GROWING IN SOME INOCULATED DISHES. CAN YOU KINDLY CONFIRM IF THERE IS PATIENT SAMPLES WERE INVOLVED? YES THERE WERE PATIENT SAMPLES INVOLVED. I. DID THE COURSE OF TREATMENT CHANGE? IF YES, PROVIDE DETAILS. THE COSTUMER IS NOT AWARE OF THIS HAPPENING. THEY IDENTIFIED THAT THE PDV MIGHT BE FAILING BECAUSE THEY SAW SOME SAMPLES WHERE THE ABUNDANCE OF BACTERIA IN GRAM STAINED SLIDES DID NOT MATCH THE ABSENCE OF GROWTH IN THE OTHER PLATES FOR THAT PATIENT. BECAUSE THEY HAVE THE GRAM STAIN AS A DOUBLECHECK, THEY MANUALLY INOCULATED THE SAMPLES AGAIN FOR A SECOND TIME IN THE SAME KIND OF PLATES AND THERE WAS GROWTH. THE ONLY CHANGE FOR THIS SAMPLES WOULD HAVE BEEN A DELAY IN REPORTING RESULTS BACK. MORE SAMPLES WITHOUT GRAM STAIN MIGHT HAVE BEEN AFFECTED BUT THE COSTUMER WAS NOT AWARE OF IT. II. WERE THERE ERRONEOUS RESULTS? IF YES, PROVIDE DETAILS. AGAIN THE COSTUMER REALIZED IN THE SAMPLES WITH THE GRAM, AND DOESN¿T KNOW IF ANY FALSE NEGATIVE MIGHT HAVE GONE OUTIN SAMPLES WITHOUT GRAM. AS FAR AS WE KNOW, THERE WERE NO ERRONEOUS RESULTS REPORTED. III. WAS THERE EXPOSURE TO BLOOD/BODILY FLUID? IF YES, PROVIDE DETAILS. NO IV. WAS THERE MEDICAL INTERVENTION? IF YES, PROVIDE DETAILS. NO

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD KIESTRA INOQULA OBTAINED A FALSE NEGATIVE RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RANDOM NO GROWING IN SOME INOCULATED DISHES. CAN YOU KINDLY CONFIRM IF THERE IS PATIENT SAMPLES WERE INVOLVED? YES THERE WERE PATIENT SAMPLES INVOLVED. I. DID THE COURSE OF TREATMENT CHANGE? IF YES, PROVIDE DETAILS. THE COSTUMER IS NOT AWARE OF THIS HAPPENING. THEY IDENTIFIED THAT THE PDV MIGHT BE FAILING BECAUSE THEY SAW SOME SAMPLES WHERE THE ABUNDANCE OF BACTERIA IN GRAM STAINED SLIDES DID NOT MATCH THE ABSENCE OF GROWTH IN THE OTHER PLATES FOR THAT PATIENT. BECAUSE THEY HAVE THE GRAM STAIN AS A DOUBLECHECK, THEY MANUALLY INOCULATED THE SAMPLES AGAIN FOR A SECOND TIME IN THE SAME KIND OF PLATES AND THERE WAS GROWTH. THE ONLY CHANGE FOR THIS SAMPLES WOULD HAVE BEEN A DELAY IN REPORTING RESULTS BACK. MORE SAMPLES WITHOUT GRAM STAIN MIGHT HAVE BEEN AFFECTED BUT THE COSTUMER WAS NOT AWARE OF IT. II. WERE THERE ERRONEOUS RESULTS? IF YES, PROVIDE DETAILS. AGAIN THE COSTUMER REALIZED IN THE SAMPLES WITH THE GRAM, AND DOESN¿T KNOW IF ANY FALSE NEGATIVE MIGHT HAVE GONE OUTIN SAMPLES WITHOUT GRAM. AS FAR AS WE KNOW, THERE WERE NO ERRONEOUS RESULTS REPORTED. III. WAS THERE EXPOSURE TO BLOOD/BODILY FLUID? IF YES, PROVIDE DETAILS. NO IV. WAS THERE MEDICAL INTERVENTION? IF YES, PROVIDE DETAILS. NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640075 BD KIESTRA INOQULA DEVICE, MICROTITER DILUTING/DISPENSING JTC BD KIESTRA LAB AUTOMATION 447202 00382904472023

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown