BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C CALCIUM

    MDR report key: 8846190 · Received July 31, 2019

    Report

    Report Number
    3002809144-2019-00477
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Report Date
    August 26, 2019
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CJY
    UDI-DI
    00380740132613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED FOR THE CUSTOMER ISSUE AND INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF TRENDING DATA, AND A REVIEW OF LABELING. A SEARCH BY PRODUCT LOT NUMBER FOR OTHER TICKETS SIMILAR TO THIS ISSUE FOUND NO SIMILAR COMPLAINTS. THE TREND REVIEW BY THE PRODUCT LIST NUMBER DID NOT IDENTIFY ANY TRENDS RELATED TO THIS ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE. 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 FALSE ELEVATED CALCIUM RESULT WHEN PROCESSING ON THE ALINITY I. THE INITIAL AND REPEAT RESULTS FOR SID (B)(6) WERE >5 AND 2.5, RESPECTIVELY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640845 ALINITY C CALCIUM CALCIUM CJY ABBOTT GERMANY UNKNOWN 00380740132613

    Patients

    Seq Age Sex Outcome Treatment
    1 ALINITY C PROCESSING MODULE, LIST 03R67-01| ALINITY C PROCESSING MODULE, LIST 03R67-01| SERIAL AC01047| SERIAL AC01047