BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG8+ CARTRIDGE

    MDR report key: 13059604 · Received December 22, 2021

    Report

    Report Number
    2245578-2021-00109
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    December 11, 2021
    Report Date
    April 27, 2022
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    UDI-DI
    10054749000163
    PMA / PMN Number
    K940918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 22-DEC-2021. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE LOT PASSED FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING FOR THE LOT MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AG, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE FOR SUPPRESSED RESULTS AND FOR POINTS OUTSIDE TOTAL ALLOWABLE ERROR (EA) FOR ALL SENSORS EXCEPT ICA. THIS RELATED DEFICIENCY IS BEING INVESTIGATED IN QUALITY RECORD (B)(4).

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). A MEMO REGARDING THE INVESTIGATION WAS COMPLETED ON 13-MAY-2022. THE MEMO DETERMINED THAT LOT W21139A WHICH WAS PREVIOUSLY IDENTIFIED AS A DEFICIENCY FOR ICA POINTS OUTSIDE TOTAL ALLOWABLE ERROR WAS INADVERTENTLY BRACKETED WITH QR 775835. AS A RESULT QR 823211 WAS INITIATED TO BRACKET LOT W21139A. THIS FOLLOW UP DOES NOT CHANGE THE OUTCOME OF THE INVESTIGATION AND SOLELY FOR BRACKETING PURPOSE.

    Description of Event or Problem · 0

    NA.

    Description of Event or Problem · 0

    ON (B)(6) 2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT IONIZED CALCIUM RESULT OF 1.56 MG/DL ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION. METHOD: I-STAT , DATE: (B)(6) 2021 , K RESULTS: 1.56 MG/DL ; METHOD: LAB , DATE: (B)(6) 2021 , K RESULTS: 0.72 MG/DL. 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
    1964484 I-STAT CG8+ CARTRIDGE CG8+ CARTRIDGE CHL ABBOTT POINT OF CARE NA W21139A 10054749000163

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown