BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT 6+ CARTRIDGE

    MDR report key: 6932269 · Received October 9, 2017

    Report

    Report Number
    2245578-2017-00331
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    November 18, 2016
    Report Date
    October 9, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749000088
    PMA / PMN Number
    K912387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 04/13/2016. RETAIN AND PRODUCT WAS TESTED AND FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. INVESTIGATION: THE CUSTOMER REPORTED OBTAINING AN UNEXPECTED K+ RESULT WHILE USING 6+ CARTRIDGE LOT K15261A TO TEST A PATIENT SAMPLE. 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 WHOLE BLOOD (WB) AND I-STAT LEVEL 1 CONTROL (L1). 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. NO REPEATS ON THE I-STAT OR LABORATORY.

    Description of Event or Problem · 1

    ON (B)(6) 2016, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT POTASSIUM (K) RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RESULTS FROM (B)(6) 2015: I-STAT K+ - 2.1, ANTECH K+ - 4.3. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. 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
    712330 I-STAT 6+ CARTRIDGE 6+ CARTRIDGE JGS ABBOTT POINT OF CARE NA K15261A 10054749000088

    Patients

    Seq Age Sex Outcome Treatment
    1