BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG4+ CARTRIDGE

    MDR report key: 13170140 · Received January 5, 2022

    Report

    Report Number
    2245578-2022-00005
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    December 15, 2021
    Report Date
    February 1, 2022
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    KHP
    UDI-DI
    10054749000132
    PMA / PMN Number
    K982071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). OTHER PRODUCT: LIST DESCRIPTION: LOT# , UDI , PMA/510K, 03P88-25, CG8+ , UNK , (B)(4) , K940918. 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 25-JAN-2022. THE CUSTOMER REPORTED OBTAINING A DISCREPANCY IN HGB PATIENT SAMPLE RESULTS BETWEEN TESTING WITH I-STAT CG4+ AND CG8+ (CARTRIDGE LOT NUMBERS UNKNOWN) AND A SYSMEX LAB INSTRUMENT. HGB IS CALCULATED FROM THE MEASURED HCT RESPONSE PER ARTWORK 765792-00 REV. B, REV. DATE: 16-SEP-2020, ISTAT CG8+ CARTRIDGE. AS HGB WOULD ONLY GENERATE AN ERRONEOUS RESULT IF THE MEASURED HCT RESPONSE IT IS DEPENDENT ON WAS INCORRECT, HCT WAS THE FOCUS OF THIS INVESTIGATION. A REVIEW OF HCT PERFORMANCE VERIFICATION DATA OF I-STAT VERSUS MULTIPLE REFERENCE INSTRUMENTS AT MULTIPLE SITES FOR CLEW A41 AND A42 DEMONSTRATES THAT THE OVERALL PERFORMANCE OF THE I-STAT HCT IS IN AGREEMENT WITH OTHER MANUFACTURERS. NO DEFICIENCY HAS BEEN DETERMINED.

    Description of Event or Problem · 0

    ON (B)(6) 2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ & CG8+ CARTRIDGES (LOT# UNK) THAT YIELDED A SUSPECTED DISCREPANT HEMOGLOBIN RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (B)(6). CUSTOMER PRESENTED TWO CARTRIDGE PRODUCTS BUT ONLY ONE I-STAT RESULT. IT IS UNKNOWN WHICH CARTRIDGE PRODUCT IS ASSOCIATED WITH THE LOT. THERE WERE MULTIPLE ATTEMPTS FOR INFORMATION BUT TO NO AVAIL. THE CUSTOMER STATED THEY SUSPECT AN ISSUE WITH THE PRE ANALYSIS OF THE SAMPLE (PB OF HOMOGENIZATION). HOWEVER, NOT CONFIRMED AT THE TIME OF THE REPORT. 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 THE 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
    1133136 I-STAT CG4+ CARTRIDGE CG4+ CARTRIDGE KHP ABBOTT POINT OF CARE NA UNK 10054749000132

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male