BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE INNOVIN

    MDR report key: 19648653 · Received July 1, 2024

    Report

    Report Number
    9610806-2024-00013
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    April 12, 2024
    Report Date
    July 24, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJS
    UDI-DI
    00842768003790
    PMA / PMN Number
    K974343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 01-JUL-2024. ADDITIONAL INFORMATION 02-JUL-2024: SIEMENS INVESTIGATION ASSESSED THE ISSUE AS FOLLOWS: REAGENT ISSUES WERE RULED OUT BASED ON REVIEW OF QUALITY CONTROLS (QC) WHICH SHOWED RECOVERY WITHIN ACCEPTABLE RANGES AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. ASSESSMENT OF INSTRUMENT PERFORMANCE INCLUDED A REVIEW OF TESTING ON ANOTHER ANALYZER. WHEN TESTED ON ANOTHER BFT II ANALYZER WITH FRESH REAGENTS, THE SAME DISCREPANCY IS OBSERVED. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT IS CONSISTENT WITH A SAMPLE SPECIFIC INTERFERENT. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE IS RESOLVED BY ROUTINE TROUBLESHOOTING. THE DADE INNOVIN LOT 564610B IS PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION D4, THE PRIMARY UDI NUMBER WAS UPDATED TO INCLUDE THE CORRECTED UNIQUE DEVICE IDENTIFIER (UDI) NUMBER. THE INITIAL MDR CONTAINED ONLY THE GLOBAL TRADE ITEM NUMBER (GTIN). IN SECTION H6, THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES WERE UPDATED.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT DISCORDANT PROTHROMBIN TIME (PT) RESULTS WITH THE DADE INNOVIN ASSAY ON A BFT II ANALYZER. QUALITY CONTROLS (QCS) RECOVERED WITHIN RANGES. PER THE LIMITATIONS SECTION OF THE DADE INNOVIN INSTRUCTIONS FOR USE (IFU): "RESULTS OF THIS TEST SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." SIEMENS IS INVESTIGATING. NOTE: THE DADE INNOVIN ASSAY IS MARKETED IN THE UNITED STATES UNDER THE MATERIAL NUMBER 10873566. THE 510(K) NUMBER DOCUMENTED IN SECTION G4 IS FOR THIS PRODUCT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DISCORDANT PROTHROMBIN TIME (PT) RESULTS MEASURED WITH THE BFT II ANALYZER COMPARED TO THE CA-500 SYSTEM AND ABOUT DISCREPANCIES OF RESULTS WITHIN RUN ON BFT II ANALYZER WHEN SAMPLE WAS MEASURED IN TWO-FOLD DETERMINATION. ONLY ONE SPECIFIC PATIENT (DESCRIBED AS PATIENT X) IS AFFECTED. ERRONEOUS RESULTS WERE NOT PROVIDED TO THE PHYSICIAN(S). THE REPEAT RESULTS ON THE CA-500 SYSTEM WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROTHROMBIN TIME RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544311 DADE INNOVIN TEST, TIME, PROTHROMBIN GJS SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH N/A 564610B 00842768003790

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female