BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 7793137 · Received August 17, 2018

    Report

    Report Number
    1628664-2018-01472
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Report Date
    October 4, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ABBOTT SERVICE REPRESENTATIVE PERFORMED ON-SITE TROUBLESHOOTING OF THE ANALYZER THAT INCLUDED SYSTEM CHECKS AND DIAGNOSTICS, SYSTEM DECONTAMINATION AND REPLACEMENT OF MULTIPLE PARTS. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2018, A SECOND SUSPECT MEDICAL DEVICE WAS ADDED. THIS INFORMATION IS IDENTICAL TO THE REPORT SENT IN MANUFACTURER REPORT 3005094123-2018-00023 AGAINST LIKELY CAUSE B-HCG REAGENTS LN 07K78-30 LOT 80244UI00. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IC COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY DEPRESSED B-HCG RESULT ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED FOR A FEMALE PREGNANT WITH TWINS: (B)(6) INITIAL 14.711 MIU/ML, REPEAT 31.00, 90.00, 99.385. A SECOND PATIENT (B)(6) INITIAL 14.219, REPEATS 14.703, 14.826, AND REPEATED ON ANOTHER METHOD AS 123.668 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634030 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 B-HCG REAGENTS| B-HCG REAGENTS| LN 07K78-30 LOT 80244UI00| LN 07K78-30 LOT 80244UI00.| B-HCG REAGENTS| LN 07K78-30 LOT 80244UI00.