BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT B-HCG CARTRIDGE

    MDR report key: 8268168 · Received January 22, 2019

    Report

    Report Number
    2245578-2019-00013
    Event Type
    Malfunction
    Date Received
    January 22, 2019
    Date of Event
    January 12, 2019
    Report Date
    February 13, 2019
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    DHA
    UDI-DI
    10054749001009
    PMA / PMN Number
    K133002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT #: (B)(4). THE INVESTIGATION WAS COMPLETED ON 02/05/2019. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED AND RETURNED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AC (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE).NO DEFICIENCY HAS BEEN IDENTIFIED FOR SS-HCG CARTRIDGE LOT F18331.

    Description of Event or Problem · 0

    NA.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED SUSPECTED FALSE POSITIVE RESULTS ON A (B)(6) FEMALE PATIENT WITH A VAGINAL BLEED. THERE WAS NO ADDITIONAL PATIENT INFORMATION. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. IT IS SUSPECTED THAT THE POSITIVE RESULTS ON I-STAT ARE POTENTIALLY RELATED TO A HETEROPHILIC ANTIBODY BUT UNCONFIRMED AT THIS TIME. THE CUSTOMER STATED THAT THE PATIENT WAS NOT PREGNANT AND WAS REFERRED TO GYNECOLOGIST. THE REPORTING DECISION WAS BASED ON 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
    61279 I-STAT B-HCG CARTRIDGE B-HCG CARTRIDGE DHA ABBOTT POINT OF CARE NA F18331 10054749001009

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR