BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG8+ CARTRIDGE

    MDR report key: 7850122 · Received September 6, 2018

    Report

    Report Number
    2245578-2018-00228
    Event Type
    Malfunction
    Date Received
    September 6, 2018
    Date of Event
    August 22, 2018
    Report Date
    October 16, 2018
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    UDI-DI
    10054749000163
    PMA / PMN Number
    K940918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT #: (B)(4). THE INVESTIGATION WAS COMPLETED ON 10/10/2018. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. WHILE RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AC (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE), A PREVIOUSLY IDENTIFIED UNRELATED ISSUE FOR THE LOT IS BEING INVESTIGATED UNDER QUALITY RECORD (QR) 2206.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2018, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULT ON A (B)(6) YEAR OLD FEMALE PATIENT WITH CHRONIC LYMPHOCYTIC LEUKEMIA. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE. METHOD: DATE: COLLECTED: TESTED: RESULT: SAMPLE: COBAS: (B)(6) 2018, 12:25, 13:03, 8.20 MMOL/L, PLASMA COLLECTED IN LITHIUM HEPARIN. I-STAT: (B)(6) 2018 , 12:25, 13:12, 7.4 MMOL/L, WB COLLECTED IN LITHIUM HEPARIN. PICCOLO XPRESS: (B)(6) 2018, 12:25, 13:16, >8.5 MMOL/L, WB COLLECTED IN LITHIUM HEPARIN. COBAS: (B)(6) 2018, 12:25, 13:23, 4.10 MMOL/L, SERUM. 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
    692471 I-STAT CG8+ CARTRIDGE CG8+ CARTRIDGE CHL ABBOTT POINT OF CARE NA W18087 10054749000163

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR