BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 22010704 · Received May 13, 2025

    Report

    Report Number
    2245578-2025-00051
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    May 5, 2025
    Report Date
    June 10, 2025
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 09-JUN-2025. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE CARTRIDGE LOTS MET FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AN (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR CK-MB CARTRIDGE LOT C25003 OR CTNI CARTRIDGE LOT S24332.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). CK-MB. PRODUCT#: 03P92-25. LOT#: C25003. MFG DATE: 03-JAN-2025. EXPIRY DATE: 19-JUN-2025. APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 0

    NA.

    Description of Event or Problem · 0

    ON 09-MAY-2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN AND CK-MB CARTRIDGES THAT YIELDED DISCREPANT FALSE POSITIVE RESULTS ON A PATIENT WITH SAMPLE 1. THERE WAS NO PATIENT INFORMATION, NOR DETAILS SURROUNDING THE EVENT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: DATE: TESTED: RESULT: SAMPLE: LOT#: CTNI, (B)(6) 2025, 7:46, 0.47 NG/ML, #1, S24332, FALSE POSITIVE. CK-MB, (B)(6) 2025, 7:57, 10.9 NG/ML, #1, C25003, FALSE POSITIVE. CTNL, (B)(6) 2025, 8:09, 0.00 NG/ML, #2, CK-MB, (B)(6) 2025, 8:16, 0.5 NG/ML, #2, CTNL, (B)(6) 2025, 10:21, 0.00 NG/ML, #3, CK-MB, (B)(6) 2025, 10:32, 0.6 NG/ML, #3, AT THIS TIME, THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATIENT SUFFERED AN MI. THE INVESTIGATION IS UNDERWAY. INTENDED USE: THE I-STAT® CARDIAC TROPONIN I (CTNI) TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUANTITATIVE MEASUREMENT OF CARDIAC TROPONIN I (CTNI) IN WHOLE BLOOD OR PLASMA. MEASUREMENTS OF CARDIAC TROPONIN I ARE USED IN THE DIAGNOSIS AND TREATMENT OF MYOCARDIAL INFARCTION AND AS AN AID IN THE RISK STRATIFICATION OF PATIENTS WITH ACUTE CORONARY SYNDROMES WITH RESPECT TO THEIR RELATIVE RISK OF MORTALITY. INTENDED USE: THE I-STAT® CK-MB TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUANTITATIVE MEASUREMENT OF CREATINE KINASE MB MASS IN WHOLE BLOOD OR PLASMA SAMPLES. CK-MB MEASUREMENTS CAN BE USED AS AN AID IN THE DIAGNOSIS AND TREATMENT OF MYOCARDIAL INFARCTION (MI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240750 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA S24332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown