BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 6927010 · Received October 7, 2017

    Report

    Report Number
    2245578-2017-00411
    Event Type
    Malfunction
    Date Received
    October 7, 2017
    Date of Event
    May 31, 2016
    Report Date
    October 6, 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
    WA, 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 08/15/2016. RETAIN PRODUCT WAS TESTED AND FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED CARTRIDGES WERE TESTED IN WHOLE BLOOD AND I-STAT CONTROL LEVEL 2. CUSTOMER COMPLAINT WAS NOT REPRODUCED. TEST RESULTS FOR THE RETAIN CARTRIDGES MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. Y, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. INVESTIGATION CONFIRMED THE LOT IS PERFORMING TO SPECIFICATION. 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 CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT CHLORIDE, SODIUM, BUN/UREA, HEMATOCRIT AND POTASSIUM RESULT ON A (B)(6) YEAR OLD MALE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT, THE PATIENT WAS TREATED BASED ON THE LAB RESULTS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. THERE WAS NO REPEAT ON I-STAT. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. METHOD: DATE: COLLECTION TIME: TEST TIME: NA: K : CL, HCT, BUN, SAMPLE: I-STAT, (B)(6) 2016, 192,3 1934, 118, 5.5, >140, 45 , 27, A. ROCHE COBAS 6000, (B)(6) 2016, 1923, 1934, 143, 4.1, 102, 48.3, 23, B. 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
    705768 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA H16024 10054749001917

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR