BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EC8+ CARTRIDGE

    MDR report key: 8540828 · Received April 23, 2019

    Report

    Report Number
    2245578-2019-00112
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    March 28, 2019
    Report Date
    March 24, 2020
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    UDI-DI
    10054749000071
    PMA / PMN Number
    K940918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 03/20/2020. THE CUSTOMER REPORTED THAT ANALYZER S/N (B)(6) PRODUCED UNEXPECTED K AND BUN RESULTS WITH EC8+ CARTRIDGES FROM LOT K18343 AND UNEXPECTED PCO2 RESULTS WITH EC8+ CARTRIDGES FROM LOT H18235A. FAILURE ANALYSIS DID NOT REPRODUCE THE COMPLAINT. ANALYZER S/N (B)(6) FUNCTIONED ACCORDING TO SPECIFICATION THROUGHOUT TESTING AND PRODUCED RESULTS THAT WERE WITHIN THE ACCEPTANCE RANGES. A ROCKETWARE SEARCH SPANNING SIX MONTHS REVEALED TWO SIMILAR INCIDENTS (NON-REPRODUCIBLE UNEXPECTED PCO2 RESULTS) AND NO EVIDENCE OF A TREND. NO DEFICIENCY HAS BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 06/24/2019. THE CUSTOMER REPORTED THAT ANALYZER S/N (B)(4) PRODUCED UNEXPECTED K AND BUN RESULTS WITH EC8+ CARTRIDGES FROM LOT K18343 AND UNEXPECTED PCO2 RESULTS WITH EC8+ CARTRIDGES FROM LOT H18235A. FAILURE ANALYSIS COULD NOT BE PERFORMED AS ANALYZER S/N (B)(4) (APOC INCIDENT (B)(4)) HAS NOT BEEN RETURNED. A ROCKETWARE SEARCH SPANNING SIX 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 06/12/2019. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AD (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN DETERMINED FOR EC8+ LOT K18343.

    Description of Event or Problem · 0

    NA.

    Additional Manufacturer Narrative · 1

    APOC INCIDENT #: (B)(4). PRODUCT#: 6000-0000, SERIAL#: (B)(4), MFG DATE: 03/04/2010. ANALYZER BEING REQUESTED FOR INVESTIGATION. 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 WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EC8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT BUN AND POTASSIUM RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD: I-STAT, DATE: (B)(6) 2019, BUN: 124 MG, POTASSIUM: 79 MMOL/L, SAMPLE: A (SUSPECT INCORRECT RESULT. POSSIBLY 7.9). I-STAT, (B)(6) 2019, 18 MG, 4.4 MMOL/L, B. COLLECT AND TEST TIMES NOT PROVIDED. 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. THERE WAS NO PATIENT INFORMATION. THE CUSTOMER STATES THAT THE POTASSIUM RESULT WAS 79 MMOL/L. HOWEVER, THE RESULT APPEARS TO BE INCORRECT. PER I-STAT SYSTEM MANUAL ART: 714174-00P, THE REPORTABLE RANGE FOR POTASSIUM IS 2.0 - 9.0 MM/L. THE CUSTOMER HAS REQUESTED THE ANALYZER BE REPLACED, AS THE ERRORS HAVE OCCURRED WITH TWO LOTS OF CARTRIDGES. THE ERRORS IN QUESTION HAVE NOT BEEN CONFIRMED AND THE PRODUCT HAS NOT BEEN REPLACED. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334385 I-STAT EC8+ CARTRIDGE EC8+ CARTRIDGE CHL ABBOTT POINT OF CARE NA K18343 10054749000071

    Patients

    Seq Age Sex Outcome Treatment
    1