BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INNOVA PLATE STREAKER

    MDR report key: 3037125 · Received March 8, 2013

    Report

    Report Number
    1119779-2013-00003
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    December 20, 2012
    Report Date
    February 8, 2013
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    MKZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BD INFORMED THE CUSTOMER OF THE ISSUE AT THE TIME IT WAS NOTICED. AS PART OF THE INVESTIGATION BD ASKED THE CUSTOMER TO EXAMINE THEIR POSITIVITY REPORTS FOR ANY DECREASES AND ALSO TO EXAMINE THE QUALITY CONTROL TESTING THEY PERFORM ON THE URINES FOR EACH DRAWER. THE CUSTOMER DID NOT SEE ANY CHANGES IN POSITIVITY LEVELS AND ALL URINE QC SAMPLES PERFORMED AS EXPECTED. AT THIS TIME, WE DO NOT KNOW OF ANY INSTANCE WHERE A CUSTOMER SAMPLE WAS REPORTED AS FALSE NEGATIVE. INVESTIGATION AT THE CUSTOMER SITE ON THE INSTRUMENT REVEALED THAT ON (B)(4) 2012 A SERVICE ENGINEER WAS ON SITE TO FIX A SEPARATE ISSUE. DURING THIS VISIT, THE RSST VALUE IN THE INSTRUMENT SPECIFIC CSV FILE WAS SET TO +90 DEGREES BUT SHOULD HAVE BEEN SET TO -90 DEGREES. THIS CAUSED THE INSTRUMENT TO NOT ALTERNATE BETWEEN TWO LOOPS WHICH ROTATE 180 DEGREES FROM EACH OTHER. THIS CASED THE INSTRUMENT TO USE ONLY ONE LOOP WHICH IN TURN DID NOT ALLOW COOL TIME BECAUSE THE LOOPS DID NOT ALTERNATE USAGE. BD DETERMINED THAT ALL ENGINEERS WERE SUFFICIENTLY TRAINED. OTHER INSTRUMENTS WERE EXAMINED AND NO OTHER EVIDENCE WAS PRESENTED TO INDICATE THE CSV FILE HAD BEEN MODIFIED. AT THIS TIME, IT APPEARS THAT THIS WAS A RESULT OF A CLERICAL MISTAKE BY THE ENGINEER SERVICING THE INSTRUMENT ON (B)(4) 2012. NO OTHER INCIDENTS OF THIS TYPE HAVE BEEN REPORTED OR DISCOVERED DURING THIS INVESTIGATION WHICH INDICATES THIS IS AN ISOLATED EVENT. A CORRECTIVE ACTION WILL BE TAKEN TO PREVENT RECURRENCE OF THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    THE BD INNOVA INSTRUMENT IS INTENDED TO COMPLETELY AUTOMATE THE FRONT-END SETUP OF LIQUID MICROBIOLOGY SAMPLES ACCORDING TO USER-DEFINED PROCEDURES AND PROTOCOLS. DURING A RECENT VISIT TO THE CUSTOMER SITE A BD FIELD SERVICE ENGINEER NOTICED THAT THERE WAS NO COOL TIME BETWEEN THE LOOP BEING STERILIZED AND THE SAMPLING FROM THE PT SPECIMEN. THE SAMPLING OF THE SPECIMEN WITH A HOT LOOP COULD POTENTIALLY CAUSE A FALSE NEGATIVE CULTURE RESULT. BD MEDICAL DEPT PROVIDED THE FOLLOWING ANALYSIS OF THE SITUATION: IN THE SETTING IN WHICH A URINARY TRACT INFECTION IS PRESENT AND A FALSE NEGATIVE RESULT IS REPORTED TO THE CLINICIAN, THE CLINICIAN MIGHT EITHER DISCONTINUE ANTIMICROBIAL THERAPY OR NOT INITIATE ANTIMICROBIAL THERAPY WHEN IT IS NEEDED. IT IS POSSIBLE THAT IF NO THERAPY IS GIVEN THE INFECTION COULD WORSEN AND LEAD TO SEPSIS WHICH MIGHT REQUIRE HOSPITALIZATION. THIS RISK WOULD BE MITIGATED IN THAT THE CLINICIAN IS LIKELY TO REPEAT CULTURES FROM THE URINE AND OTHER SOURCES IF THE PT HAD CONTINUED TO HAVE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100449 BD INNOVA PLATE STREAKER MKZ BD DIAGNOSTIC SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other