BEUDAMED
    FDA Adverse Event Death Summary report: N

    XPERT MRSA/SA BC

    MDR report key: 1675196 · Received May 4, 2010

    Report

    Report Number
    3004530258-2010-00001
    Event Type
    Death
    Date Received
    May 4, 2010
    Date of Event
    April 11, 2010
    Report Date
    May 3, 2010
    Manufacturer
    CEPHEID
    Product Code
    NQX
    PMA / PMN Number
    K082140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTENDED USE OF DEVICE: THE CEPHEID XPERT (B) (6) BLOOD CULTURE ASSAY PERFORMED ON THE GENEXPERT DX SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC TEST INTENDED FOR THE DETECTION OF (B) (6) AND (B) (6) DNA DIRECTLY FROM PT POSITIVE BLOOD CULTURES. THE ASSAY UTILIZES AUTOMATED REAL-TIME POLYMERASE CHAIN REACTION (PCR) FOR THE AMPLIFICATION OF (B) (6) SPECIFIC DNA TARGETS AND FLUOROGENIC TARGET-SPECIFIC HYBRIDIZATION PROBES FOR THE REAL-TIME DETECTION OF THE AMPLIFIED DNA. THE ASSAY IS PERFORMED DIRECTLY ON POSITIVE BLOOD CULTURE SPECIMENS USING BD BACTEC PLUS AEROBIC/F BLOOD CULTURE BOTTLES THAT ARE DETERMINED AS GRAM POSITIVE (B) (6) IN CLUSTERS (B) (6) OR AS GRAM POSITIVE (B) (6) IN SINGLES (B) (6) BY GRAM STAIN. THE CEPHEID XPERT (B) (6) BLOOD CULTURE ASSAY IS NOT INTENDED TO MONITOR TREATMENT FOR (B) (6) INFECTIONS. SUBCULTURING OF POSITIVE BLOOD CULTURES IS NECESSARY TO RECOVER ORGANISMS FOR SUSCEPTIBILITY TESTING OR FOR EPIDEMIOLOGICAL TYPING. CEPHEID CONTACT FOR MDR: (B) (4), VICE PRESIDENT, REGULATORY COMPLIANCE & QUALITY SYSTEMS, CEPHEID. (B) (4). (B) (4)

    Description of Event or Problem · 1

    ON APRIL 1, A (B) (6) MALE WAS ADMITTED TO HOSPITAL COMPLAINING OF BACK PAIN; PT HAD A HISTORY OF RENAL INSUFFICIENCY AND CONGESTIVE HEART FAILURE. ON APRIL 6, PT BECOMES FEBRILE, BLOOD WAS DRAWN FOR BLOOD CULTURE AND TEST WAS POSITIVE BY CEPHEID GX (B) (6)/SA BC ASSAY FOR (B) (6). ON APRIL 7, PT WAS TREATED WITH INVANZ (ERTAPENEM) ANTIBIOTIC; PT FELL IN ROOM, HIT HEAD, CARDIAC ARREST, WAS REVIVED AND SENT TO ICU; NASAL SWAB TAKEN FOR (B) (6) CULTURE TEST; PT GIVEN 1500 MG VANCOMYCIN. ON APRIL 8, PT WAS GIVEN OXACILLIN. ON APRIL 9, BLOOD CULTURE AGAR PLATE WAS POSITIVE FOR (B) (6) AND APRIL 6, CULTURE SAMPLE REPEATED ON CEPHEID GX (B) (6)/SA BC TEST WAS NOW (B) (6) POSITIVE; HOSPITAL LAB CONTACTED CEPHEID TO REPORT THE DISCREPANCY IN TEST RESULTS (B) (4). ON APRIL 11, THE PT EXPIRED. ON APRIL 28, A MEETING WAS HELD BETWEEN HOSPITAL LAB PERSONNEL AND CEPHEID PERSONNEL TO REVIEW THE DETAILS OF THE COMPLAINT DURING WHICH CEPHEID LEARNED FOR FIRST TIME PT HAD DIED. CEPHEID BEGAN MDR PROCESS FOLLOWING INTERNAL PROCEDURE AS SPECIFIED IN (B) (4) (MEDICAL DEVICE REPORTING SOP. ON APRIL 29 AND APRIL 30 FOLLOW UP MEETINGS WERE HELD WITH LAB PATHOLOGIST DR (B) (6) TO CONFIRM DETAILS OF COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERT MRSA/SA BC NONE NQX CEPHEID 1302

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death