BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 15382987 · Received September 8, 2022

    Report

    Report Number
    2245578-2022-00130
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    September 3, 2022
    Report Date
    November 18, 2022
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749005519
    PMA / PMN Number
    K183688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). ANALYZER INVESTIGATION (896411): THE INVESTIGATION WAS COMPLETED ON 16-NOV-2022. THE CUSTOMER REPORTED THAT ANALYZER S/N (B)(6) WAS GIVING DISCREPANT PATIENT RESULTS FOR POTASSIUM (K) AND CREATININE (CREA) WHILE RUNNING I-STAT CHEM8+ CARTRIDGES FROM LOTS H22138 AND H22164 WITH I-STAT CONTROL LEVEL 1 (LOT 101144), 3 (LOT 121145), AND CALIBRATION VERIFICATION SET (LOT 21258). ADDITIONALLY, THE ANALYZER PRODUCED HIGH CHLORIDE (CI) AND LOW UREA NITROGEN (BUN) RESULTS. FAILURE ANALYSIS COULD NOT BE PERFORMED AS ANALYZER S/N (B)(6) HAS NOT BEEN RETURNED TO FLEX. A ROCKETWARE SEARCH SPANNING THREE MONTHS REVEALED NO SIMILAR INCIDENTS AND NO EVIDENCE OF A TREND. NO DEFICIENCY HAS BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 28-SEP-2022. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT PASSED FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AK, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT. I-STAT PRODUCT INFORMATION: PRODUCT# 04P75-35, SERIAL # (B)(4). 26-SEP-2011. APOC INCIDENT # (B)(4).

    Description of Event or Problem · 0

    ON 06-SEP-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES AND I-STAT SN (B)(4) THAT YIELDED A SUSPECTED DISCREPANT RESULT OF 2.5 ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. ANALYZER SN (B)(4) IS BEING REPLACED AT NO CHARGE AND WILL BE INVESTIGATED SEPARATELY. (B)(6). 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
    280807 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA H22138 10054749005519

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female