BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT B-HCG CARTRIDGE

    MDR report key: 19073951 · Received April 9, 2024

    Report

    Report Number
    2245578-2024-00079
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    April 4, 2024
    Report Date
    May 20, 2024
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    DHA
    PMA / PMN Number
    K133002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON (B)(6) 2024. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE CARTRIDGE LOTS MET FINISHED GOODS RELEASE CRITERIA. RETAINED AND RETURNED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AN (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR TOTAL B-HCG CARTRIDGE LOTS F23343 AND F24033.

    Description of Event or Problem · 0

    ON 04-APR-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED POSITIVE RESULTS ON A 27 YEAR OLD FEMALE PATIENT WITH NAUSEA AND VOMITTING FOR 3 DAYS PLUS SHORTNESS OF BREATH AND DRY MOUTH. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD COLLECTED RESULT (UNITS) SAMPLE I-STAT 8:45 112.9 IU/L A SIEMENS 8:45 <2 MIU/ML B I-STAT 8:45 109.2 IU/L A SIEMENS 8:45 <2 MIU/ML B I-STAT 1249 80.7 IU/L D SIEMENS 8:45 <2 MIU/ML E DATE AND TEST TIME NOT PROVIDED. CUSTOMER STATES THAT CARTRIDGE LOTS F233433 & F240334 ARE ASSOCIATED WITH THE EVENT. HOWEVER, IT LOTS ARE NOT SPECIFIED FOR EACH TEST. 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. I-STAT POSITIVE CUT-OFF VALUES: B-HCG < 5.0 IU/L NEGATIVE 5.0 < SS-HCG < 25.0 IU/L INDETERMINATE B-HCG >25.0 IU/L POSITIVE INTENDED USE: THE I-STAT® TOTAL BETA-HUMAN CHORIONIC GONADOTROPIN (B-HCG) TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUANTITATIVE AND QUALITATIVE DETERMINATION OF B-HCG IN VENOUS WHOLE BLOOD OR PLASMA SAMPLES USING THE I-STAT 1 ANALYZER SYSTEMS. THE TEST IS INTENDED TO BE USED AS AN AID IN THE EARLY DETECTION OF PREGNANCY AND IS FOR PRESCRIPTION USE ONLY.

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539218 I-STAT B-HCG CARTRIDGE B-HCG CARTRIDGE DHA ABBOTT POINT OF CARE NA F23343

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female