BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT 6+ CARTRIDGE

    MDR report key: 10972252 · Received December 8, 2020

    Report

    Report Number
    2245578-2020-00131
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Date of Event
    November 15, 2020
    Report Date
    December 15, 2020
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749000088
    PMA / PMN Number
    K912387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: (B)(4). THE INVESTIGATION WAS COMPLETED ON 10-DEC-2020. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AF, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN DETERMINED FOR 6+ LOT K20207.

    Additional Manufacturer Narrative · 1

    APOC INCIDENT # (B)(6). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT 6+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT SODIUM RESULT OF 119 MMOL/L ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD DATE RESULT : I-STAT (B)(6) 2020 119 MMOL/L, I-STAT (B)(6) 2020 141 MMOL/L, I-STAT (B)(6) 2020 122 MMOL/L, I-STAT (B)(6) 2020 138 MMOL/L, CUSTOMER DID NOT PROVIDE SAMPLE TEST OR COLLECTION TIMES. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. 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
    1436649 I-STAT 6+ CARTRIDGE 6+ CARTRIDGE JGS ABBOTT POINT OF CARE NA K20207 10054749000088

    Patients

    Seq Age Sex Outcome Treatment
    1