BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT CELITE CARTRIDGE

    MDR report key: 6932432 · Received October 9, 2017

    Report

    Report Number
    2245578-2017-00378
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    September 6, 2016
    Report Date
    October 9, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JBP
    UDI-DI
    10054749000149
    PMA / PMN Number
    K992571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APOC INCIDENT (B)(4). APOC LABELING WAS EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT. THE INVESTIGATION WAS COMPLETED ON 11/21/2016. RETAIN AND RETURN PRODUCT WAS TESTED AND FOUND TO BE FUNCTIONING ACCORDING TO SPECIFICATION. INVESTIGATION: THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED. THE LOT PASSED FINISHED GOODS RELEASE CRITERIA. FORTY RETAINED AND 98 RETURNED CARTRIDGES WERE TESTED USING WHOLE BLOOD AS WELL AS BLOOD SAMPLES WHICH SIMULATE PATIENTS UNDERGOING ORAL ANTICOAGULANT THERAPY. TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV Z, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED. ASSESSMENT: THE COMPLAINT INVESTIGATION CONCLUDED THERE WAS NO PRODUCT DEFICIENCY AND THAT THE I-STAT CARTRIDGE LOT IS MEETING SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2016, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT CELITE CARTRIDGES THAT YIELDED UNEXPECTED RESULTS ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. TEST TIME: 0934, ACT: 423. 0954, 224. 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
    712082 I-STAT ACT CELITE CARTRIDGE ACT CELITE CARTRIDGE JBP ABBOTT POINT OF CARE NA R16217 10054749000149

    Patients

    Seq Age Sex Outcome Treatment
    1