BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMYLASE

    MDR report key: 15451296 · Received September 19, 2022

    Report

    Report Number
    3002809144-2022-00330
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    September 2, 2022
    Report Date
    December 15, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    JFJ
    UDI-DI
    00380740161668
    PMA / PMN Number
    K981653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER: MULTIPLE = (B)(6).

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, TRENDING DATA REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND INVESTIGATION BY THE THIRD PARTY MANUFACTURER OF THE RETAINED REAGENT LOT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE THIRD PARTY MANUFACTURER, SEKISUI, INVESTIGATED THE COMPLAINT BY SCANNING 14 CARTRIDGES OF GLUCOSE REAGENT LOT 61585UQ02 AND 15 CARTRIDGES OF AMYLASE REAGENT LOT 61453UQ01 FROM SEVERAL RETAINED KITS ON AN ARCHITECT SYSTEM. ALL LABELS SCANNED APPROPRIATELY WITH NO ERRORS FOUND. THE TICKET SEARCH BY LOT DID NOT IDENTIFY ABNORMAL COMPLAINT ACTIVITY FOR THE CURRENT COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS RELATED TO THE COMPLAINT LIST NUMBER AND ISSUE. REVIEW OF PRODUCT LABELING WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE AMYLASE REAGENT KIT, LOT 61453UQ01, WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER IDENTIFIED AN ISSUE WITH THE ARCHITECT AMYLASE REAGENT ON THE ARCHITECT C16000. THE CUSTOMER OBTAINED MULTIPLE (SAMPLE ID (B)(6)) INACCURATE GLUCOSE RESULT THAT WERE FLAGGED <0.28 MMOL/L. WHEN THE ANALYZER WAS INSPECTED THEY FOUND AMYLASE IN THE CAROUSEL POSITION THE ANALYZER INDICATED GLUCOSE WAS IN THEREFORE INDICATING THE ANALYZER MAY HAVE READ THE AMYLASE REAGENT AS GLUCOSE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2837388 AMYLASE CATALYTIC METHODS, AMYLASE JFJ ABBOTT GMBH 7D58-22 61453UQ01 00380740161668

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC C16K PRC MOD, 03L77-01, (B)(6) | ARC C16K PRC MOD, 03L77-01, (B)(6)