BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 9236251 · Received October 24, 2019

    Report

    Report Number
    3002809144-2019-00722
    Event Type
    Malfunction
    Date Received
    October 24, 2019
    Report Date
    October 24, 2019
    Manufacturer
    ABBOTT GERMANY
    Product Code
    JJE
    UDI-DI
    00380740137366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED FOR THE CUSTOMER ISSUE AND INCLUDED A REVIEW OF THE COMPLAINT TEXT, TROUBLESHOOTING, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF THE SERVICE HISTORY OF THE AI01289, A REVIEW OF ASSAY PERFORMANCE, AND A REVIEW OF PRODUCT LABELING. THE FIELD SERVICE ENGINEER (FSE) REPLACED TUBING FITTINGS ON THE ANALYZER. THE ISSUE WAS CONSIDERED TO BE RESOLVED AFTER A DEGASSER (NON-ABBOTT COMPONENT) WAS INSTALLED ON (B)(6) 2019. THE ALINITY I ANALYZER AI01289 (LIST NUMBER 03R65-01) WAS CONSIDERED THE LIKELY CAUSE FOR THIS ISSUE. NO SIMILAR ISSUES AS DESCRIBED IN THIS COMPLAINT WERE IDENTIFIED. A REVIEW OF THE AI01289 SERVICE HISTORY WAS PERFORMED AND FOUND NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. NO SYSTEMIC ISSUE WAS IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE ELEVATED HIGH SENSITIVE TROPONIN RESULT WHEN PROCESSING ON THE ALINITY I. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): 384.8 NG/L AND 450.7 NG/L. SID (B)(6): 12.8 NG/L AND 15.2 NG/L. SID (B)(6): 59.8 NG/L AND 68.0 NG/L. SID (B)(6): 26.4 NG/L AND 23.9 NG/L. SID (B)(6): 87.6 NG/L AND 98.0 NG/L. SID (B)(6): 105.0 NG/L AND 121.6 NG/L (FEMALE, (B)(6) YEAR). SID (B)(6): 35.3 NG/L, 15.5 NG/L, AND <10 NG/L. SID (B)(6): 18.8, 85.6, 18.2 NG/L, AND 19.7 NG/L (FEMALE, (B)(6) YEAR). SID (B)(6): 39.7 NG/L AND 45.7 NG/L (MALE, (B)(6) YEAR). SID (B)(6): 65.1 NG/L AND 79.8 NGL (MALE, (B)(6) YEAR). SID (B)(6): 689.6 NG/L, 802.1 NG/L, 822.6 NG/L AND 894.6 NG/L. SID (B)(6): 201.1, 272.4, 268, AND 266 NG/L (MALE, (B)(6) YEAR). THE CUSTOMER USES A CUTOFF OF 15.6 PG/ML FOR FEMALES AND 34.2 PG/ML FOR MALES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030749 ALINITY I PROCESSING MODULE AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT GERMANY 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1