BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 12790479 · Received November 10, 2021

    Report

    Report Number
    3002809144-2021-00643
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    September 30, 2021
    Report Date
    December 17, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING SITE VISIT BY ABBOTT FIELD SERVICE (FSR), THE ALINITY (B)(6) PROCESSING MODULE WAS INSPECTED, AND PERFORMED TROUBLESHOOTING INCLUDED PART REPLACEMENT. A SPECIFIC CAUSE(S) WAS NOT IDENTIFIED. A REVIEW OF THE ANALYZER SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. THE TREND REVIEW BY THE PRODUCT LIST NUMBER FOUND NO TRENDS RELATED TO THIS ISSUE. A REVIEW OF THE (B)(6) SERVICE HISTORY WAS PERFORMED AND NO ADDITIONAL ERRATIC RESULTS PRE- OR POST THE CURRENT COMPLAINT WERE IDENTIFIED. THE ALINITY CI-SERIES OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AND TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM. THE OPERATIONS MANUAL ALSO ADDRESSES TROUBLESHOOTING OF ELEVATED CONCENTRATION AND ERRATIC SAMPLE RESULTS. PER LABELING REVIEW, ALINITY C CALCIUM PACKAGE INSERT ADEQUATELY ADDRESSES SAMPLE PREPARATION AND HANDLING AND ENSURE CONSISTENCY IN RESULTS. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6).

    Additional Manufacturer Narrative · 0

    THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3002809144-2021-00612-01 UNDER A DIFFERENT SUSPECT DEVICE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED CALCIUM RESULTS ON ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) INITIAL=0.71 MMOL/L /REPEATED ON ANOTHER ALINITY=2.27, AND 2.31 MMOL/L. REFERENCE RANGE FOR CALCIUM= 2.10 TO 2.25 MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689528 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT GMBH 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY C CALCIUM RGT 400, 07P57-20, 49044UN21| ALNTY C CALCIUM RGT 400, 07P57-20, 49044UN21