BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERSANT HIV-1 RNA 3.0 ASSAY (BDNA)

    MDR report key: 1731382 · Received June 15, 2010

    Report

    Report Number
    3003932969-2010-00002
    Event Type
    Other
    Date Received
    June 15, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 26, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MZP
    PMA / PMN Number
    BP000028
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND RUN DATA INDICATE THAT THE CAUSE OF THE FALSELY LOW VALUE IS UNK. THE ASSAY IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. FOR MEDICAL DEVICE REPORTING PURPOSES, THIS EVENT IS CONSIDERED CLOSED. ADDITIONAL CATALOG #: 04484744.

    Description of Event or Problem · 1

    A FALSELY LOW PT VALUE WAS PRODUCED WITH THE VERSANT (B)(6). THE RESULT WAS REPORTED TO THE TREATING PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAMPLE WAS RETESTED AND GAVE A SIGNIFICANTLY HIGHER RESULT. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS INCIDENT.

    Additional Manufacturer Narrative · 2

    ANALYSIS OF THE INSTRUMENT AND RUN DATA INDICATE THAT THE CAUSE OF THE FALSELY LOW VALUE IS UNK. THE ASSAY IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED. ADDITIONAL CATALOG #: 04484744.

    Description of Event or Problem · 2

    A FALSELY LOW PT VALUE WAS PRODUCED WITH THE VERSANT (B)(6). THE RESULT WAS REPORTED TO THE TREATING PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAMPLE WAS RETESTED AND GAVE A SIGNIFICANTLY HIGHER RESULT. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSANT HIV-1 RNA 3.0 ASSAY (BDNA) VERSANT HIV-1 RNA 3.0 ASSAY (BDNA) MZP SIEMENS HEALTHCARE DIAGNOSTICS INC. NA REAGENTS:D079

    Patients

    Seq Age Sex Outcome Treatment
    1 Other
    2 Other