BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH TOTAL BILIRUBIN_2 (TBIL_2)

    MDR report key: 20216906 · Received September 13, 2024

    Report

    Report Number
    2432235-2024-00206
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 3, 2024
    Report Date
    October 15, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JFM
    UDI-DI
    00630414595818
    PMA / PMN Number
    K170065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION (20-SEP-2024): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER. NO REAGENT OR INSTRUMENT ISSUES WERE IDENTIFIED. QUALITY CONTROL (QC) RECOVERED WITHIN THE CUSTOMER¿S ACCEPTABLE RANGES. THE CAUSE OF THE EVENT IS UNKNOWN. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. INITIAL MDR WAS FILED ON 13-SEP-2024.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING AN ERRONEOUSLY DEPRESSED TOTAL BILIRUBIN_2 (TBIL_2) NEONATE PATIENT RESULT OBTAINED ON AN ATELLICA CH 930 INSTRUMENT. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ERRONEOUSLY DEPRESSED TOTAL BILIRUBIN_2 (TBIL_2) NEONATE PATIENT SAMPLE RESULT WAS OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT AS THE NEONATE HAD JAUNDICE. A SECOND (DIFFERENT) SAMPLE WAS PROCESSED ON AN ALTERNATE SIEMENS METHODOLOGY (RP500E BLOOD GAS ANALYZER). A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED TOTAL BILIRUBIN_2 (TBIL_2) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114123 ATELLICA CH TOTAL BILIRUBIN_2 (TBIL_2) ENZYMATIC METHOD, BILIRUBIN JFM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 140170 00630414595818

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Unknown