BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM 8+ CARTRIDGE

    MDR report key: 6938664 · Received October 10, 2017

    Report

    Report Number
    2245578-2017-00554
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    March 16, 2017
    Report Date
    October 10, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749001917
    PMA / PMN Number
    K053110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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 06/08/2017. RETAIN AND RETURN PRODUCT WAS TESTED AND FUNCTIONING ACCORDING TO SPECIFICATION. INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT PASSED FINISHED GOODS RELEASE CRITERIA. RETAIN CARTRIDGE TEST DATA MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. Z, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. RETURN SAMPLE SIZE WAS INSUFFICIENT TO MAKE A PASS/FAIL DETERMINATION ON ACCEPTABILITY OF THE RATE OF RESULTS OUTSIDE EA AS PER Q04.01.003 REV. Z, APPENDIX 1. NO K OR BUN RESULTS OUTSIDE EA LIMITS WERE OBSERVED. 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. THERE IS NOT ENOUGH INFORMATION TO DETERMINE WHETHER AN I-STAT PRODUCT MALFUNCTION OCCURRED FOR K+. THE TIMING OF THE TWO TESTS AND INFORMATION ABOUT THE SAMPLE ARE UNKNOWN. NO REPEATS ON EITHER SYSTEM.

    Description of Event or Problem · 1

    ON (B)(4) 2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT POTASSIUM AND BUN ON A (B)(6) YEAR OLD MALE PATIENT WITH ABDOMINAL PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. THERE WAS NO REPEAT ON I-STAT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. I-STAT: POTASSIUM 6.3 AND A BUN OF 35; LAB: POTASSIUM 3.9 AND A BUN OF 24. 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
    717267 I-STAT CHEM 8+ CARTRIDGE CHEM 8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA H16351A 10054749001917

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR