BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ESTRADIOL REAGENT KIT

    MDR report key: 13389181 · Received January 28, 2022

    Report

    Report Number
    3005094123-2022-00022
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Date of Event
    January 12, 2022
    Report Date
    May 10, 2022
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    CHP
    UDI-DI
    00380740129910
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A COMPLAINT TRENDING REVIEW DETERMINED THAT THERE IS NO ADVERSE TREND FOR THE PRODUCT FOR THE COMPLAINT ISSUE. NO ELEVATED COMPLAINT ACTIVITY WAS IDENTIFIED FOR LOT 32197UD00. NO ADVERSE TRENDS WERE IDENTIFIED. LABELING REVIEW DETERMINED THAT THERE IS SUFFICIENT LABELING TO AID THE CUSTOMER IN TROUBLESHOOTING THIS ISSUE. A REVIEW OF THE PRODUCT QUALITY HISTORY FOR THE LOT NUMBER 32197UD00 USING SEARCH OF THE CORRECTIVE AND PREVENTIVE ACTIONS SYSTEM DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER OBSERVATION. ACCURACY TESTING WAS PERFORMED USING THE COMPLAINT LOT. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET, DEMONSTRATING THAT THE LOT IS PERFORMING ACCEPTABLY. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER DOES NOT CONTAIN ENOUGH SPACES, THE ENTIRE ID IS (B)(6). CONTACT PHONE, THE ENTIRE PHONE IS (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE PROVIDED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION B.5 UPDATED INFORMATION: ALINITY I ESTRADIOL <1000 (SERIAL (B)(6)) TO ALINITY I ESTRADIOL >1000 (SERIAL (B)(6)). AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE PROVIDED WHEN THE EVALUATION IS COMPLETE.SECTION B.5 UPDATED INFORMATION: ALINITY I ESTRADIOL <1000 (SERIAL (B)(6)) TO ALINITY I ESTRADIOL >1000 (SERIAL (B)(6)).

    Description of Event or Problem · 0

    THE ACCOUNT QUESTIONED THE DIFFERENCE IN ALINITY I ESTRADIOL RESULTS ON A PATIENT SAMPLE PROCESSED ON 2 ALINITY I PROCESSING MODULES. THE ACCOUNT DOES NOT KNOW WHICH ANALYZER GENERATED THE CORRECT RESULTS FOR SID (B)(6), BUT THE RESULTS FROM SERIAL (B)(4) WERE REPORTED OUT OF THE LAB. ON (B)(6) 2022 SID (B)(6) (FEMALE) GENERATED: ALINITY I ESTRADIOL > 1000.00, 1469.89, 1491.87, 1438.42, 1442.22 PG/ML (SERIAL (B)(4)). ALINITY I ESTRADIOL 916.48. 928.19 PG/ML (SERIAL (B)(4)). ALINITY I ESTRADIOL <1000, 1473.60, 1424.74, 1430.25 PG/ML (SERIAL (B)(4)). HISTORICAL PATIENT VALUES: 125 PG/ML (ON (B)(6)2021), 104 PG/ML (ON (B)(6)2021), 360 PG/ML (ON (B)(6)2021), 120 PG/ML (ON (B)(6)2021), 61 PG/ML (ON (B)(6)2021), 91 PG/ML (ON (B)(6)2021). NO OTHER SPECIFIC PATIENT INFORMATION IS AVAILABLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    UPDATED INFORMATION: ALINITY I ESTRADIOL >1000 (SERIAL (B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510665 ALINITY I ESTRADIOL REAGENT KIT RADIOIMMUNOASSAY, ESTRADIOL CHP A.I.D.D LONGFORD 07P5020 32197UD00 00380740129910

    Patients

    Seq Age Sex Outcome Treatment
    1 Female ALNTY I PROCESSING MODU 03R65-01, AI20506, AI20839| ALNTY I PROCESSING MODU 03R65-01, AI20506, AI20839| ALNTY I PROCESSING MODU 03R65-01, AI20506, AI20839