BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 9109678 · Received September 24, 2019

    Report

    Report Number
    3002809144-2019-00575
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    September 7, 2019
    Report Date
    November 18, 2019
    Manufacturer
    ABBOTT GERMANY
    Product Code
    JJE
    UDI-DI
    00380740137380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING WHICH INCLUDED RESEATING THE ICT MODULE ASSAY CABLES AND THE DAQ BOARD. THE ICT MODULE WAS DETERMINED TO BE THE LIKELY CAUSE. A REVIEW OF SERVICE HISTORY FOR THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(4), REVEALED NO ADDITIONAL DISCREPANT POTASSIUM RESULTS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING DID NOT REVEAL ANY TRENDS FOR THE ICT MODULE. A REVIEW OF TRACKING AND TRENDING DID NOT REVEAL ANY TRENDS FOR THE ALINITY C. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE LIKELY CAUSE PART OR THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION NO SYSTEM ISSUE OR DEFICIENCY OF THE ICT MODULE OR ALINITY C PROCESSING MODULE, SERIAL (B)(4) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION: NO FURTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED POTASSIUM RESULTS GENERATED ON THE ALINITY C ANALYZER FOR 11 PATIENTS. ON (B)(6) 2019 FOR ABOUT 2 HOURS 11 SAMPLES GENERATED A POTASSIUM RESULT OF 3.9 MMOL/L. ER PHYSICIAN QUESTIONED THE LAB WHEN A PATIENT'S SYMPTOMS DIDN'T MATCH THE 3.9 MMOL/L RESULT AND ABG IN ER SHOWED HYPOKALEMIA. REPEAT OF THE SAMPLE ON ANOTHER ANALYZER = 1.5 MMO//L SID (B)(6). ADDITIONAL PATIENT SAMPLES WERE THEN FOUND TO BE DISCREPANT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904189 ALINITY C PROCESSING MODULE AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT GERMANY 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1