BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM 1300 ANALYZER

    MDR report key: 24915602 · Received April 17, 2026

    Report

    Report Number
    2432235-2026-00095
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 17, 2026
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414007960
    PMA / PMN Number
    K151792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT THAT A TROPONIN (TNIH) TEST WAS PERFORMED ON AN ATELLICA IM 1300 ANALYZER BUT NOT SENT TO THE DATA MANAGEMENT SOFTWARE (DMS) FOR VALIDATION. THE SAMPLE TESTED INITIALLY TRIGGERED AN ALARM STATING "SVC: SIGNAL ERROR (SIGNAL SHAPE ERROR)" AND DID NOT PRODUCE A RESULT WHEN PROCESSED UNDILUTED. THIS ERROR DID NOT APPEAR IN DMS. THE SAMPLE WAS MARKED AS ¿IN PROGRESS¿ IN THE DMS. THE CUSTOMER MANUALLY DILUTED THE SAMPLE AND REPEAT TESTING WAS PERFORMED. A RESULT WAS THEN OBTAINED WITHOUT ERROR. REAGENT RELATED CAUSES WERE RULED OUT BASED ON REVIEW OF THE QUALITY CONTROLS (QC) WHICH SHOWED RECOVERY WITHIN ACCEPTABLE RANGES. THE RELATIVE LIGHT UNITS (RLU) OF THE UNDILUTED RESULT WAS 32839044. THE S10 HIGHEST MASTER CURVE STANDARD (LOT 113) RLU IS 11682972. THE DILUTED SPECIMEN LOWERED THE RLU VALUE SUFFICIENTLY FOR THE SAMPLE TO READ ON CURVE AND GENERATE A RESULT WITHOUT THE SIGNAL SHAPE ERROR. SIEMENS FURTHER EVALUATED THE EVENT AND CONCLUDED THE PROBABLE CAUSE OF THE SIGNAL SHAPE ERROR IS SAMPLE RELATED BASED ON THE AVAILABLE INFORMATION. ACCORDING TO THE CUSTOMER FACING DOCUMENT, ATELLICA SOLUTION OPERATOR¿S GUIDE, SIGNAL SHAPE ERRORS ARE NOT TRANSMITTED TO THE LABORATORY INFORMATION SYSTEM (LIS). THE DEVICE PERFORMED WITHIN SPECIFICATIONS DURING THE EVENT. THE CUSTOMER IS OPERATIONAL. THE COMPLAINT WAS RESOLVED WITH ROUTINE TROUBLESHOOTING.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A TROPONIN (TNIH) TEST WAS PERFORMED ON A PATIENT SAMPLE. THE SAMPLE TESTED INITIALLY TRIGGERED AN ALARM STATING "SVC: SIGNAL ERROR (SIGNAL SHAPE ERROR)". THE ALARM WAS NOT TRANSMITTED TO THE DATA MANAGEMENT SOFTWARE (DMS) AND NOT SENT TO THE DMS FOR VALIDATION. IT IS STILL MARKED AS "IN PROGRESS" STATUS IN THE DMS ON AN ATELLICA IM 1300 ANALYZER. THERE WAS THEREFORE A THREE-HOUR DELAY THAT WAS UNAPPARENT TO THE CUSTOMER BEFORE THE DECISION WAS MADE TO DILUTE THE SAMPLE AND OBTAINED TNIH RESULTS TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404307 ATELLICA IM 1300 ANALYZER ATELLICA IM 1300 ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1300 ANALYZER 00630414007960

    Patients

    Seq Age Sex Outcome Treatment
    1