BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 6769653 · Received August 4, 2017

    Report

    Report Number
    2245578-2017-00245
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Date of Event
    August 8, 2016
    Report Date
    August 4, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    UDI-DI
    10054749001986
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APOC LABELING WAS EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT. THE INVESTIGATION WAS COMPLETED ON (B)(6) 2016. RETAIN PRODUCT WAS TESTED AND FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. Z (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR CTNI CARTRIDGE LOT K16032. ASSESSMENT: THE RESULTS WITHIN EACH SYSTEM ARE CONSISTENT. BASED ON THE I-STAT NEGATIVE RESULT AND THE RESULT FROM ANOTHER MANUFACTURER BEING POSITIVE AND THE LIMITED PATIENT INFORMATION, THERE IS NOT ENOUGH INFORMATION TO DETERMINE WHETHER AN I-STAT PRODUCT MALFUNCTION OCCURRED. THE FDA GUIDANCE DOCUMENT (TROPONIN: WHAT LABORATORIANS SHOULD KNOW TO MANAGE ELEVATED RESULTS) CAUTIONS AGAINST COMPARING ASSAY RESULTS ACROSS TWO INSTRUMENT PLATFORMS. HAMA OR OTHER HETEROPHILE ANTIBODIES, MAY INTERFERE WITH IMMUNOASSAYS AND PRODUCE ERRONEOUS RESULTS AND THE MAGNITUDE OF THE INTERFERENCE MAY BE DIFFERENT BETWEEN PLATFORMS. AS PER THE PRODUCT LABELLING (CARTRIDGE AND TESTING INSTRUCTIONS-CTI SHEET), "RESULTS FROM THE I-STAT CTNI ASSAY SHOULD BE CONSIDERED IN THE CONTEXT OF THE ENTIRETY OF THE AVAILABLE CLINICAL INFORMATION." "AN ELEVATED TROPONIN VALUE ALONE IS NOT SUFFICIENT TO DIAGNOSE A MYOCARDIAL INFARCTION. RATHER, THE PATIENT'S CLINICAL PRESENTATION (HISTORY, PHYSICAL EXAM) AND ECG SHOULD BE USED IN CONJUNCTION WITH TROPONIN IN THE DIAGNOSTIC EVALUATION OF SUSPECTED MYOCARDIAL INFARCTION."

    Description of Event or Problem · 1

    ON (B)(6) 2016, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT NEGATIVE RESULT OF 0.00 ON A (B)(6) FEMALE PATIENT PRESENTED TO THE ED FOR CHEST PAIN AND HEADACHE. THE PATIENT WAS TREATED BASED ON THE REFERENCE ANALYZER AND THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. NO RETURN PRODUCT AVAILABLE FOR INVESTIGATION. TROPONIN TESTING WAS CONDUCTED ON 3 I-STAT ANALYZERS, ALL RESULTS WERE 0.00. SAMPLES DRAWN AT THE SAME TIMES WERE TESTED ON A BECKMAN COULTER ACCESS. RESULTS WERE 4.0, 3.4 AND 3.4. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY APOC, HOWEVER THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED MAY 8TH TO 12TH, 2017 AT ABBOTT POINT OF CARE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546484 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA K16032 10054749001986

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR