BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR TOTAL HCG (THCG) AND PROGESTERONE

    MDR report key: 1628717 · Received March 5, 2010

    Report

    Report Number
    1219913-2010-00028
    Event Type
    Other
    Date Received
    March 5, 2010
    Date of Event
    February 17, 2010
    Report Date
    February 18, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JHI
    PMA / PMN Number
    K925277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT # 138. EXPIRATION DATE: 12/3/2010. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE ELEVATED ADVIA CENTAUR TOTAL HCG AND PROGESTERONE PT RESULTS IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. PRGE 510K #: K932955.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: A SERVICE VISIT FROM A REGIONAL SPECIALIST WAS REQUESTED AND INVESTIGATION CONDUCTED A FEW DAYS FOLLOWING THE INCIDENT. BASED ON THE DISCUSSION, THE CAUSE OF THE DUPLICATE SID IN THE RACK, AND OF THE DISCORDANT RESULTS, WAS THE STAT PIN MISSING FROM THE STAT LOADER, A KNOWN ISSUE THAT WAS COMMUNICATED TO THE FIELD IN SUPPORT BULLETIN (B)(4). THE STAT RACK PUSHER BLOCK (WITH STAT PIN) WAS REPLACED AS PER THE SUPPORT BULLETIN, TO CORRECT THE ISSUE.

    Description of Event or Problem · 1

    A FALSE NEGATIVE ADVIA CENTAUR TOTAL HCG AND A LOW PROGESTERONE PT RESULTS WERE OBTAINED BY THE CUSTOMER AND REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULTS. THE CUSTOMER REPEATED THE TESTING AND THE EXPECTED RESULTS WERE OBTAINED. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOTAL HCG AND PROGESTERONE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR TOTAL HCG (THCG) AND PROGESTERONE TOTAL HCG AND PRGE IMMUNOASSAY JHI SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 228

    Patients

    Seq Age Sex Outcome Treatment
    1