BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 9088080 · Received September 19, 2019

    Report

    Report Number
    3002809144-2019-00560
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Date of Event
    August 27, 2019
    Report Date
    October 1, 2019
    Manufacturer
    ABBOTT GERMANY
    Product Code
    JJE
    UDI-DI
    00380740137380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ABBOTT FIELD SERVICE (FS) INVESTIGATED THE ISSUE ON SITE. FS TROUBLESHOOTING INCLUDED MANUALLY CLEANING THE CUVETTES AND REPLACING THE DRY TIP. THERE HAVE BEEN NO FURTHER REPORTS OF DISCREPANT RESULTS SINCE THE CUVETTES WERE CLEANED AND THE DRY TIP REPLACED. A REVIEW OF THE AC01196 SERVICE HISTORY WAS NOT ABLE TO IDENTIFY OR CONFIRM ANY ADDITIONAL LIKELY CAUSES. A REVIEW OF HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES. A REVIEW OF THE CLINICAL CHEMISTRY SYSTEMS REVEALED FOUND NO SYSTEMIC ISSUES OR TRENDS FOR THE ISSUE ASSOCIATED WITH THIS TICKET (ERRATIC/DISCREPANT RESULTS). A REVIEW OF LABELLING ADEQUATELY ADDRESSES SAMPLE RESULTS OBSERVED PROBLEMS FOR ERRATIC / DISCREPANT RESULTS. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY C ANALYZER.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. PATIENT IDENTIFIERS: SIDS (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED CREATININE RESULTS GENERATED ON THE ALINITY C ANALYZER ON SEVEN PATIENTS. RESULTS PROVIDED (UMOL/L): (B)(6) = 376 / NEW SAMPLE (B)(6) 2019 = 40 / 41. (B)(6) 2019 SID (B)(6) = 251 / 83. (B)(6) 2019 SID (B)(6) = 217 / 69. (B)(6) 2019 SID (B)(6) = 191 / 118. (B)(6) 2019 SID (B)(6) = 191 / 77. (B)(6) 2019 SID (B)(6) = 191 / 120. (B)(6) 2019 SID (B)(6) = 244 / 119. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882219 ALINITY C PROCESSING MODULE AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT GERMANY 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 ALINITY C CREATININE LIST 08P01-30| LOT 90145Y600