BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 3243335 · Received July 23, 2013

    Report

    Report Number
    1226181-2013-00330
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    DHA
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCORDANT, FALSE NEGATIVE HCG RESULT IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION (08/01/13): DURING FOLLOW-UP WITH THE CUSTOMER, THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC) SPECIALIST WAS INFORMED THAT THE CUSTOMER HAD RESEATED AND REALIGNED THE REAGENT PROBE, AS THEY HAD BEEN ADVISED TO DURING TROUBLESHOOTING. QUALITY CONTROLS WERE RUN, ALL OF WHICH WERE WITHIN RANGE. THE PATIENT SAMPLE WAS THEN RERUN AND RESULTED AS EXPECTED. THE CAUSE OF THE DISCORDANT, FALSE NEGATIVE HCG RESULT WAS A MALFUNCTION OF THE REAGENT PROBE. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSE NEGATIVE HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE OPERATOR DISCOVERED THAT THE NEGATIVE RESULT DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT AND INFORMED THE EMERGENCY ROOM STAFF THAT THE SAMPLE WOULD BE RERUN AND TO HOLD THE INITIAL RESULT. THE SAMPLE WAS RERUN ON AN ALTERNATE INSTRUMENT AND RESULTED HIGHER. THE RERUN RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE NEGATIVE HCG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344198 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER DHA SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1