BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 6932488 · Received October 9, 2017

    Report

    Report Number
    2245578-2017-00550
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    January 15, 2016
    Report Date
    October 9, 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
    SC, 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 04/21/2017. RETAIN AND RETURN PRODUCT WAS TESTED AND THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED AND RETURNED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. Z (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). 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) 2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A (B)(6) MALE PATIENT FOR NAUSEA, VOMITING AND CHILLS. THE PATIENT WAS NOT ADMITTED AND LATER DISCHARGED. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. DATE: (B)(6)2017, SAMPLE: A, METHOD: I-STAT, DRAWN:1116, TESTED: 1119, NA: 3.5, K: 42, HCT:14.3, HB:>138, CI. (B)(6) 2017, B, COBAS, 1116, 1232, 140, 4.4, 46.4, 15.7, 102, SYSMEX RESULTS (HEMATOLOGY ANALYZER) . 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
    709032 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA H16301A 10054749001917

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR