BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 7603696 · Received June 14, 2018

    Report

    Report Number
    3002809144-2018-00061
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    May 21, 2018
    Report Date
    July 14, 2018
    Manufacturer
    ABBOTT GERMANY
    Product Code
    JJE
    UDI-DI
    00380740137380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE CUSTOMER ISSUE INCLUDED A COMPLAINT TEXT REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, A LABELING REVIEW, INSTRUMENT LOG REVIEW, AND AN INSTRUMENT SERVICE REVIEW. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. LOG REVIEW DID NOT IDENTIFY ANY ISSUES THAT CONTRIBUTED TO THE CUSTOMER ISSUE. SERVICE HISTORY REVIEW IDENTIFIED NO CONTRIBUTING FACTORS TO THE CUSTOMER ISSUE. RETURNS WERE NOT AVAILABLE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS EVALUATION, NO SYSTEMIC ISSUE WAS IDENTIFIED AND NO PRODUCT DEFICIENCY WAS FOUND. DATE OF EVENT WAS UPDATED AS MAY 21, 2018.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN EVALUATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED MULTIPLE FALSELY DEPRESSED CALCIUM (CA) RESULTS AND A FALSELY DEPRESSED SODIUM (NA) RESULTS WHILE USING THE ALINITY C ANALYZER. THE FOLLOWING DATA WAS PROVIDED. CALCIUM (CA): (B)(6) INITIAL 3 MG/DL, REPEAT 4.3, 8.3, 9.2, 10.65 MG/DL; (B)(6) INITIAL 2.5 MG/DL, REPEAT 5, 7, 8, 9.32 MG/DL; (B)(6) INITIAL 3.7 MG/DL, REPEAT 5.7, 8.8 MG/DL. SODIUM (NA): (B)(6) INITIAL 145 MMOL/L, REPEAT 163, 163 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446359 ALINITY C PROCESSING MODULE AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT GERMANY 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 CLINICAL CHEMISTRY CALCIUM| CLINICAL CHEMISTRY CALCIUM| LIST 07P57-30 LOT UNKNOWN| LIST 07P57-30 LOT UNKNOWN| SODIUM REAGENT LIST AND LOT UNKNOWN| SODIUM REAGENT LIST AND LOT UNKNOWN