BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 13059606 · Received December 22, 2021

    Report

    Report Number
    2245578-2021-00108
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    December 4, 2021
    Report Date
    January 25, 2022
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749005519
    PMA / PMN Number
    K053110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 21-JAN-2022. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AG, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. A PREVIOUSLY IDENTIFIED UNRELATED DEFICIENCY (FOR QUALITY CHECK CODES RELATED TO LEAKS) HAS BEEN IDENTIFIED FOR CHEM8+ CARTRIDGE LOT H21302 AND IS BEING INVESTIGATED UNDER QUALITY RECORD 802806.

    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 07-DEC-2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULT OF >9 MMOL/L ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE. METHOD: I-STAT; LAB; TEST/COLLECTION. DATE: (B)(6) 2021; (B)(6) 2021 ; TIMES NOT PROVIDED. RESULT (K): >9.0 MMOL/L ; 4.0 MMOL/L. SAMPLE: A;B. 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 WAS NO RESULT TIMES, SAMPLE HANDLING OR PATIENT INFORMATION PROVIDED AT THE TIME OF THIS REPORT. CUSTOMER CONTACTED MULTIPLE TIMES BUT TO NO AVAIL. HEMOLYSIS IS SUSPECTED ON THE I-STAT SAMPLE A BUT COULD NOT BE CONFIRMED. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964487 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA H21302 10054749005519

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown