BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 13789992 · Received March 16, 2022

    Report

    Report Number
    2245578-2022-00044
    Event Type
    Malfunction
    Date Received
    March 16, 2022
    Date of Event
    February 22, 2022
    Report Date
    March 29, 2022
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749001917
    PMA / PMN Number
    K053110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). 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 21-MAR-2022. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE EC8+ LOT PASSED FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING OF K21307 MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AG, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD AND RETAINED CARTRIDGE LOT TESTING WAS NOT APPLICABLE FOR THE CREA OR CHEM8+ LOT AS THE LOT NUMBER WAS UNKNOWN. SEARCHES OF QUALITY SYSTEM PROCESSES (QUALITY RECORDS, STABILITY AND COMPLAINTS) SHOW NO INDICATION OF RELATED PERFORMANCE ISSUES IDENTIFIED WITH UNEXPECTED CREA RESULTS DURING THE TIMEFRAME OF THIS INCIDENT. NO DEFICIENCY HAS BEEN IDENTIFIED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EC8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS OF 2.1 MG/DL ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. I-STAT 18:13 BUN 59 MG/DL WB, I-STAT 18:13 CREA 2.1 MG/DL WB, I-STAT 18:18 BUN 59MG/DL WB, I-STAT 18:13 CREA 2.1MG/DL WB, VS2 18:18 BUN 17 WB, VS2 18:18 CREA 1.1 WB. REDREW ANOTHER SAMPLE AND SENT TO LAB. BUN 18 (6-21) AND CREA 1.1 (0.5-1.6). 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 THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. NOTE: MULTIPLE ATTEMPTS FOR PRODUCT/LOT# INFORMATION BUT TO NO AVAIL AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780675 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA NI 10054749001917

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown