BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 10138321 · Received June 10, 2020

    Report

    Report Number
    2245578-2020-00068
    Event Type
    Malfunction
    Date Received
    June 10, 2020
    Date of Event
    June 4, 2020
    Report Date
    August 3, 2020
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749005519
    PMA / PMN Number
    K053110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). CLARIFICATION FOR CORRECTION. THIS IS NOT AN ADVERSE EVENT. SECTION B1. FROM: ADVERSE EVENT. TO: PRODUCT PROBLEM. SECTION B2: FROM: {X} OTHER SERIOUS (IMPORTANT MEDICAL EVENTS). TO: { } OTHER SERIOUS (IMPORTANT MEDICAL EVENTS).

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # 831875. THE INVESTIGATION WAS COMPLETED ON 07/30/2020. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AF (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN DETERMINED FOR CHEM8+ LOT H20117A.

    Description of Event or Problem · 0

    NA.

    Additional Manufacturer Narrative · 1

    APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULT OF 5.6 ON A (B)(6) YEAR OLD MALE PATIENT WITH CHEST PAIN AND SHORTNESS OF BREATH. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: (B)(6) 2020, COLLECTED: 0305, RESULT: 5.6 MMOL/L, SAMPLE: A. LAB, (B)(6)2020, NI, 3.0 MMOL/L, NI. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601571 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA H20117A 10054749005519

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other