BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG8+ CARTRIDGE

    MDR report key: 17001712 · Received May 25, 2023

    Report

    Report Number
    2245578-2023-00062
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Date of Event
    May 22, 2023
    Report Date
    June 14, 2023
    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 # 920523. CHEM8+: H23077, 600-9008-25, EXP:14-SEP-2023, MFG: 18-MAR-2023, GTIN: 10054749005519, 510K: K183688. CHEM8+: H23046, 600-9008-25, EXP: 14-AUG-2023, MFG: 15-FEB-2023, GTIN: 10054749005519, 510K: K183688. APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 13-JUN-2023. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) CONFIRMED THE CARTRIDGE LOTS MET FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AK, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN DETERMINED FOR CHEM8+ CARTRIDGE LOTS H23046 OR H23077 OR CG8+ CARTRIDGE LOT W22291.

    Description of Event or Problem · 0

    ON (B)(6) 2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ & CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT IONIZED CALCIUM RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. THERE WERE NO TEST TIMES/DATE PRESENTED WITH THE RESULTS. METHOD: LOT#: ICA: I-STAT W22291 2.5 MMOL/L, I-STAT H23077 2.5 MMOL/L ADDITIONAL LOT USED, I-STAT H23046 2.4 MMOL/L ADDITIONAL LOT USED, VETSTAT N/A 1.21 (REF RANGE 1.25-1.5). 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.

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848679 I-STAT CG8+ CARTRIDGE CG8+ CARTRIDGE CHL ABBOTT POINT OF CARE NA W22291 10054749000163

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown