BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD KIESTRA¿ INOQULA+¿ TLA

    MDR report key: 8898828 · Received August 15, 2019

    Report

    Report Number
    3010141591-2019-00136
    Event Type
    Injury
    Date Received
    August 15, 2019
    Date of Event
    July 18, 2019
    Report Date
    July 31, 2019
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTC
    UDI-DI
    00382904472139
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1119779-07/23/2019-004-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD CORRECTION INITIATED ON 26 JULY, 2019. CAPA# (B)(4) HAS BEEN OPENED TO FURTHER INVESTIGATE THIS ISSUE. AN ANOMALY WAS DISCOVERED IN INOQULA SOFTWARE (B)(6) THAT HAD THE POTENTIAL TO CAUSE A MISMATCH BETWEEN A SPECIMEN AND PLATE. THE MISMATCH COULD HAPPEN WHEN THE FOLLOWING CONDITIONS OCCUR TOGETHER. INOQULA HARDWARE IS NOT OPERATING, SUCH AS DURING A POWER OUTAGE. PIPETTE HAS ALREADY DRAWN A SPECIMEN WAITING TO BE DISPENSED ON A PLATE, AND USER SELECTS THE ¿RESET¿ FUNCTION FROM THE SYSTEM MENU. AN IMMEDIATE UPDATE TO THE SOFTWARE WAS MADE AND VALIDATED. ALL IMPACTED CUSTOMERS WERE PROVIDED WITH THE UPDATE AND INFORMATION ON ANY MIS-ASSOCIATED DATA IN THEIR SYSTEM. THIS WAS DONE VIA A RECALL AND AN 806 FORM WAS SUBMITTED ON 5 AUGUST, 2019.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD KIESTRA¿ INOQULA+¿ TO PROCESS PATIENT URINE SAMPLES, THE CUSTOMER REPORTED DISCREPANCIES IN BACTERIAL GROWTH BETWEEN THE BLOOD AGAR PLATES AND THE MACCONKRY AGAR PLATES BEING USED FOR CULTURE AFTER A POWER OUTAGE. FOLLOWING THE DISCOVERY OF THE DISCREPANCY, INSTRUMENT LOG FILES CONFIRMED PIPETTING ERRORS. DURING THIS REVIEW, THE CUSTOMER CONFIRMED INCORRECT PATIENT RESULTS WERE REPORTED OUT. THE INITIAL REPORTED RESULT WAS CITROBACTER AND E. COLI, AND AFTER REPLATING THE SPECIMEN, THE RESULT WAS AMENDED TO NO GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693011 BD KIESTRA¿ INOQULA+¿ TLA MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT JTC BD KIESTRA LAB AUTOMATION 00382904472139

    Patients

    Seq Age Sex Outcome Treatment
    1 Other