BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ESTRADIOL

    MDR report key: 3781890 · Received April 30, 2014

    Report

    Report Number
    3005094123-2014-00011
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 7, 2014
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    NO PATIENT SAMPLE OR PRODUCT RETURN WAS RECEIVED. TESTING WAS PERFORMED USING A RETAINED KIT OF ARCHITECT ESTRADIOL LOT 34908UI00. CONTROLS AND PANELS WERE EVALUATED. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET. A REVIEW OF HISTORICAL TESTING WAS PERFORMED WHICH INDICATED THAT LOT 34908UI00 PASSED ALL THE REQUIRED SPECIFICATIONS. A REVIEW OF ALL NON-CONFORMANCE REPORTS AND DEVIATIONS ASSOCIATED WITH ARCHITECT ESTRADIOL REAGENT LOT 34908UI00 AND ALL ASSOCIATED SUB-LOT NUMBERS DEMONSTRATED THAT THERE HAVE BEEN NO KNOWN QUALITY ISSUES IN RELATION TO THIS PRODUCT SINCE MANUFACTURE. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT ESTRADIOL REAGENT PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION / DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT DECREASED ARCHITECT ESTRADIOL RESULTS WERE GENERATED. AN INITIAL RESULT OF 2657 PMOL/L WAS GENERATED WITH SID (B)(6). A NEW SAMPLE (SID (B)(6)) 2 DAYS LATER GENERATED AN ESTRADIOL RESULT OF 807 PMOL/L. THE TWO SAMPLES WERE REPEATED AND GENERATED SIMILAR RESULTS. SID (B)(6): 2562 PMOL/L; SID (B)(6): 810 PMOL/L. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259392 ARCHITECT ESTRADIOL ESTRADIOL JLW A.I.D.D LONGFORD 34908UI00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER 3M74-02| SN (B)(4)| ARCHITECT I2000SR ANALYZER 3M74-02| SN (B)(4)