BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT 6+ CARTRIDGE

    MDR report key: 12540074 · Received September 28, 2021

    Report

    Report Number
    2245578-2021-00076
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    September 14, 2021
    Report Date
    November 16, 2021
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749000088
    PMA / PMN Number
    K912387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4) THE INVESTIGATION WAS COMPLETED ON 15-NOV-2021. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AG (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN DETERMINED FOR 6+ CARTRIDGE LOT K21080.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT 6+ CARTRIDGES THAT YIELDED A SUSPECTED A DISCREPANT POTASSIUM RESULT OF 4.5 MMOL/L ON A PATIENT. THERE WAS NO PATIENT INFORMATION, COLLECTION, TEST TIMES AVAILABLE AT THE TIME OF THIS REPORT. METHOD RESULT (UNITS): I-STAT 4.5 MMOL/L, LAB 7.1MMOL/L. 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
    1441033 I-STAT 6+ CARTRIDGE 6+ CARTRIDGE JGS ABBOTT POINT OF CARE NA K21080 10054749000088

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown