BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 17956852 · Received October 18, 2023

    Report

    Report Number
    2245578-2023-00142
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    October 10, 2023
    Report Date
    December 19, 2023
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 12-DEC-2023. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AL, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN DETERMINED FOR CHEM8+ CARTRIDGE LOT H23235.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON (B)(6) 2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PRODUCT (UNK) THAT YIELDED A SUSPECTED DISCREPANT RESULTS ON A PATIENT. THERE WAS NO PRODUCT INFORMATION, TEST/COLLECTION TIMES, DATES, NOR DETAILS SURROUNDING THE EVENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD K RESULT(UNIT) SAMPLE: I-STAT 5.0 (MMOL/L) NI, LAB 3.3 VENOUS. 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
    539500 NI NI JGS ABBOTT POINT OF CARE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown