BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EC4+CARTRIDGE

    MDR report key: 6938668 · Received October 10, 2017

    Report

    Report Number
    2245578-2017-00535
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    March 11, 2017
    Report Date
    October 10, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749000095
    PMA / PMN Number
    K912387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 04/05/2016. RETAIN PRODUCT WAS TESTED AND FUNCTIONING ACCORDING TO SPECIFICATION. INVESTIGATION: THE DEVICE HISTORY RECORD (DHR) FOR THIS LOT WAS REVIEWED. THE LOT PASSED FINISHED GOODS (FG) RELEASE CRITERIA. FORTY RETAINED CARTRIDGES FROM THE LOT WERE TESTED USING A WHOLE BLOOD (WB) AND A LOW HCT BLOOD SAMPLE. THE COMPLIANT WAS NOT REPRODUCED. TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. X, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. THREE HUNDRED RETURNED CARTRIDGES FROM THE LOT WERE TESTED USING WB AND LOW HCT BLOOD SAMPLES AND I-STAT LEVEL 1 CONTROL (L1). THE COMPLAINT WAS NOT REPRODUCED. TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. X, 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. THE SAMPLES WERE CONTRIVED FOR USE IN AN INTERNAL APOC VERIFICATION STUDY. 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 SODIUM ASSAY IS 18 MM UP TO 146 MM AND 14 MM AFTER THAT.

    Description of Event or Problem · 1

    ON (B)(6) 2015, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EC4+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT HCT RESULTS. THE ISSUE OCCURED INTERNALLY DURING VERIFICATION. THERE WAS NO PATIENT TESTING PERFORMED. (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)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717271 I-STAT EC4+CARTRIDGE EC4+ CARTRIDGE JGS ABBOTT POINT OF CARE NA K15273 10054749000095

    Patients

    Seq Age Sex Outcome Treatment
    1