BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT PT/INR CARTRIDGE

    MDR report key: 6938596 · Received October 10, 2017

    Report

    Report Number
    2245578-2017-00390
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    July 29, 2015
    Report Date
    October 10, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    GJS
    UDI-DI
    00054749000173
    PMA / PMN Number
    K020355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 10/05/2015. RETAIN 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 CARTRIDGES WERE TESTED USING BLOOD SAMPLES WHICH SIMULATE PATIENTS UNDERGOING ORAL ANTICOAGULANT THERAPY. TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV W, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. THE COMPLAINT WAS NOT REPRODUCED. ASSESSMENT: THERE IS NOT ENOUGH INFORMATION TO DETERMINE WHETHER AN I-STAT PRODUCT MALFUNCTION OCCURRED. THE COMPLAINT INVESTIGATION CONCLUDED THERE WAS NO PRODUCT DEFICIENCY AND THAT THE I-STAT CARTRIDGE LOT IS MEETING SPECIFICATION. LIMITS FOR ERRONEOUS RESULTS (LER) - PATIENT RESULTS INSIDE THE LER ZONE POSE A RISK TO PATIENT SAFETY. WHEN VALUES FALL INSIDE THE LER ZONES, POTENTIAL HARM CAN OCCUR TO THE PATIENTS IF THESE RESULTS ARE UTILIZED IN MEDICAL DECISION-MAKING. THE LER ESTABLISHED FOR THE I-STAT PT/INR IS 1 INR.

    Description of Event or Problem · 1

    ON (B)(6) 2015, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED UNEXPECTED RESULTS ON AN (B)(6) MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (B)(6). 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
    715484 I-STAT PT/INR CARTRIDGE PT/INR CARTRIDGE GJS ABBOTT POINT OF CARE NA T15120 00054749000173

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR