BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 6759202 · Received August 1, 2017

    Report

    Report Number
    2245578-2017-00081
    Event Type
    Malfunction
    Date Received
    August 1, 2017
    Date of Event
    March 16, 2016
    Report Date
    August 1, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    UDI-DI
    10054749000187
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 05/24/2016. RETAIN PRODUCTS WERE TESTED AND FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. THE CUSTOMER DID NOT PROVIDE CARTRIDGE LOT USED IN TESTING, HOWEVER, CARTRIDGE DISTRIBUTION RECORDS HAS IDENTIFIED THAT THE FOLLOWING CARTRIDGE LOTS WERE SHIPPED TO THE CUSTOMER WHO ALLEGED THE DISCREPANCY. LOT NUMBER: U15299; DATE SHIPPED: DEC 2015; EXPIRATION DATE: 14-MAY-2016; MANUFACTURE DATE: 26-OCT-2015; U15284 ; DEC 2015; 28-APR-2016; 11-OCT-2015; U15322; 01-FEB-2016 ; 14-JUN-2016; 18-NOV-2015; U16008; 08-MAR-2016 ; 28-JUL-2016; 08- JAN-2016. INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) CONFIRMED THAT THE CARTRIDGE LOTS MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED TESTING MET THE ACCEPTANCE CRITERIA FOR DETECTED ERROR (DT) AND UNDETECTED ERROR (UDT) RATES OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. W (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR CTNI CARTRIDGE LOTS U15284, U15299, U15322 AND U16008. ASSESSMENT: BASED ON THE REPORTEDLY DISCREPANT WHOLE BLOOD AND PLASMA RESULTS ON ANIMAL BLOOD, AND THE LIMITED INFORMATION REGARDING THE ANIMAL AND HOW THE SAMPLES WERE DRAWN AND HANDLED, 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)(4) 2016 ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED TESTING THE I-STAT CTNI CARTRIDGE ON ANIMALS AND WANTED TO UNDERSTAND THE DIFFERENCE IN RESULTS BETWEEN BLOOD AND PLASMAS. THE CUSTOMER DID NOT PROVIDE CARTRIDGE LOT USED IN TESTING. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT. NO RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. DATE: UNKNOWN; SPECIMEN : A; TYPE: WB; COLLECTED: UNKNOWN; TEST TIME:UNKNOWN; RESULT: 0.05; SERIAL # UNKNOWN. UNKNOWN; A; PLASMA; UNKNOWN; UNKNOWN ; 0.09; UNKNOWN. 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
    538983 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA SEE H10 10054749000187

    Patients

    Seq Age Sex Outcome Treatment
    1