BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 10380456 · Received August 7, 2020

    Report

    Report Number
    3002809144-2020-00787
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    July 21, 2020
    Report Date
    August 27, 2020
    Manufacturer
    ABBOTT GMBH
    Product Code
    JJE
    UDI-DI
    00380740137380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED A SITE VISIT, INSPECTED THE INSTRUMENT, AND OBSERVED FLUID LEAKING FROM THE CUVETTE WASHER HIGH CONCENTRATION WASTE (HCW) NOZZLE #1. THE FSR REPLACED THE HCW PERISTALTIC PUMP HEAD TUBING TO RESOLVE THE ISSUE. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. THE TUBING, PERISTALTIC HEAD (ROHS), PART NUMBER 7-202464-01, WAS DETERMINED TO BE THE LIKELY CAUSE FOR THE ISSUE. THE SERVICE HISTORY REVIEW DETERMINED ONE ADDITIONAL SERVICE TICKET RELATED TO THE CURRENT COMPLAINT THAT WAS INITIATED ONE DAY PRIOR TO THE CURRENT COMPLAINT DUE TO DRIPPING FROM THE CUVETTE WASHER. THE RESOLUTION FOR THIS ISSUE APPEARS TO HAVE BEEN CAPTURED IN THE CURRENT COMPLAINT. THERE WERE NO ADDITIONAL COMPLAINTS ASSOCIATED WITH THIS ISSUE. A REVIEW OF TRACKING AND TRENDING IDENTIFIED NO TRENDS OR SYSTEMIC ISSUES FOR PART NUMBER 7-202464-01 TUBING, PERISTALTIC HEAD (ROHS). THE DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR ISSUES FOR THE PART ASSOCIATED WITH THE COMPLAINT. PRODUCT LABELING REVIEW PROVIDES ADEQUATE INFORMATION. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6).

    Additional Manufacturer Narrative · 1

    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 REPORTED A FALSELY DECREASED SODIUM (NA) RESULT ON THE ALINITY C PROCESSING MODULE FOR A PATIENT ON (B)(6) 2020. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: 136 TO 145 MMOL/L): SID (B)(6) = NA RESULT = 115 MMOL/L, REPEAT = 140 MMOL/L. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843901 ALINITY C PROCESSING MODULE AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT GMBH N/A N/A 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1