BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 9077639 · Received September 17, 2019

    Report

    Report Number
    2245578-2019-00220
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    August 26, 2019
    Report Date
    September 24, 2019
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749001917
    PMA / PMN Number
    K053110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 09/24/2019. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE LOTS PASSED FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING FOR BOTH LOTS MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AD, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 1

    APOC INCIDENT (B)(4). CG8+ CARTRIDGE INFORMATION: PRODUCT: 03P88-25, LOT#: W19120, UDI: (B)(4), PMA/510(K): K940918, MFG DATE: 4/30/2019, EXPIRE DATE: 12/28/2019. APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2019, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ AND CG8+CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT HEMATOCRIT RESULTS OF <15% WITH TWO LOTS ON PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (B)(6). 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. THERE WERE MULTIPLE ATTEMPTS TO OBTAIN INFORMATION BUT TO NO AVAIL. PRODUCT LOT #'S ARE UNKNOWN AT THIS TIME. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871552 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA H19175 10054749001917

    Patients

    Seq Age Sex Outcome Treatment
    1