BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT PROLACTIN REAGENT KIT

    MDR report key: 17589650 · Received August 21, 2023

    Report

    Report Number
    3005094123-2023-00223
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    July 7, 2023
    Report Date
    October 5, 2023
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CFT
    UDI-DI
    00380740014865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTION D4 EXPIRATION DATE: TO 9/26/2023 FROM 8/26/2023. THE COMPLAINT EVALUATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW AND IN-HOUSE TESTING FOR ARCHITECT PROLACTIN REAGENT LOT NUMBER 45111UD00. THE TICKET TRENDING REVIEW OF AT LEAST 12 MONTHS COMPLAINT DATA FOR THE LIKELY CAUSE LIST NUMBER DOES NOT IDENTIFY ANY NON-STATISTICAL TREND. THE TRENDING REPORT REVIEW DETERMINED THAT THERE ARE NO TRENDS FOR THE PRODUCT FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT(S) AND COMPLAINT ISSUE. IN-HOUSE TESTING MEETS ACCEPTANCE CRITERIA, AND THE PRODUCT IS PERFORMING AS EXPECTED. SPECIMENS FROM PATIENTS WHO HAVE RECEIVED PREPARATIONS OF MOUSE MONOCLONAL ANTIBODIES FOR DIAGNOSIS OR THERAPY MAY CONTAIN HUMAN ANTI-MOUSE ANTIBODIES (HAMA). SUCH SPECIMENS MAY SHOW EITHER FALSELY ELEVATED OR DEPRESSED VALUES WHEN TESTED WITH ASSAY KITS SUCH AS ARCHITECT PROLACTIN THAT EMPLOY MOUSE MONOCLONAL ANTIBODIES. ADDITIONAL INFORMATION MAY BE REQUIRED FOR DIAGNOSIS. PROLACTIN MAY EXIST IN ALTERNATE STRUCTURAL FORMS (E.G., MACROPROLACTIN) WHICH MAY EXHIBIT VARIABLE LEVELS OF PHYSIOLOGICAL ACTIVITY. IN PATIENTS WITH ELEVATED PROLACTIN RESULTS, ADDITIONAL INFORMATION MAY BE REQUIRED FOR DIAGNOSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT PROLACTIN REAGENT LOT NUMBER 45111UD00. UPDATED INFORMATION IN SECTION G1: CONTACT OFFICE ADDRESS 1, CONTACT OFFICE CITY, CONTACT OFFICE POSTAL CODE, CONTACT OFFICE COUNTRY, CONTACT OFFICE FIRST AND LAST NAME, CONTACT OFFICE EMAIL, CONTACT OFFICE PHONE NUMBER, CONTACT OFFICE FAX NUMBER.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS WHICH QUESTIONED BY THE PHYSICIAN ON MULTIPLE PATIENTS. THE CUSTOMER SENT OUT MULTIPLE TIMES SPECIMENS AT QUEST DIAGNOSTIC LABORATORY FOR REPEAT ON PROLACTIN AND MONOMERIC PROLACTIN WHICH ARE NORMAL ACCORDING TO QUEST REFERENCE RANGE. THE RESULT PROVIDED WERE: PATIENT 1 81YRS OLD MALE: ON 02AUG2022 AT QUEST TOTAL PROLACTIN=11.2 NG/ML; MONOMERIC PROLACTIN=5.2 NG/ML 20AUG2019 ARCHITECT PROLACTIN RESULT= 42.05 NG/ML /SENT SAMPLE TO QUEST RESULTS: TOTAL PROLACTIN= 12.4 NG/ML; MONOMERIC PROLACTIN= 4.0 NG/ML; PREVIOUS HISTORY: 21AUG2018 ARCHITECT PROLACTIN RESULT= 71.71 NG/ML /SENT SAMPLE TO QUEST RESULTS: TOTAL PROLACTIN= 16.4 NG/ML; MONOMERIC PROLACTIN= 4.6NG/ML /ON 12FEB2015=57.04 NG/ML/ON 30JUN2015=93.82 NG/ML /ON 17SEP2015=29.19 NG/ML /ON 28OCT2015= 43.92 NG/ML /ON 04DEC2015=7.36 NG/ML /ON 08JUN2016=12.82 /ON 02SEP2016=62.82 NG/ML /ON 10NOV2016=5.59 NG/ML / ON 22MAY2017= 4.62 NG/ML /ON 28NOV2017=7.77 NG/ML /ON 09MAY2018=28.43 NG/ML /30MAY2018=25.89 NG/ML /21AUG2018=71.71 NG/ML /ON 18SEP2018 AT QUEST TOTAL PROLACTIN= 16.4 NG/ML; PROLACTIN,MONOMERIC=4.6 NG/ML PATIENT 2: 64YRS OLD MALE: ARCHITECT PROLACTIN RESULT ON 07JUL2023 ARCHITECT PROLACTIN RESULT= 23.0 NG/ML /SENT SAMPLE TO QUEST RESULTS: TOTAL PROLACTIN= 15.4 NG/ML; MONOMERIC PROLACTIN= 9.0 NG/ML /ON 16MAR2023= 24.4 NG/ML /SENT SAMPLE TO QUEST RESULTS: TOTAL PROLACTIN= 11.2; MONOMERIC PROLACTIN= 5.2NG/ML /PREVIOUS HISTORY: ON 02DEC2022=20.2 H NG/ML LABORATORY REFERENCE RANGE FOR ABBOTT PROLACTIN= MALE; 3-19 NG/ML; QUEST TOTAL PROLACTIN=2.0 TO 18 NG/ML; MONOMERIC PROLACTIN=3.4 TO 14.8 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS WHICH QUESTIONED BY THE PHYSICIAN ON MULTIPLE PATIENTS. THE CUSTOMER SENT OUT MULTIPLE TIMES SPECIMENS AT QUEST DIAGNOSTIC LABORATORY FOR REPEAT ON PROLACTIN AND MONOMERIC PROLACTIN WHICH ARE NORMAL ACCORDING TO QUEST REFERENCE RANGE. THE RESULT PROVIDED WERE: PATIENT 1 81YRS OLD MALE: ON (B)(6) 2022 AT QUEST TOTAL PROLACTIN=11.2 NG/ML; MONOMERIC PROLACTIN=5.2 NG/ML. (B)(6) 2019 ARCHITECT PROLACTIN RESULT= 42.05 NG/ML /SENT SAMPLE TO QUEST RESULTS: TOTAL PROLACTIN= 12.4 NG/ML; MONOMERIC PROLACTIN= 4.0 NG/ML; PREVIOUS HISTORY: (B)(6) 2018 ARCHITECT PROLACTIN RESULT= 71.71 NG/ML /SENT SAMPLE TO QUEST RESULTS: TOTAL PROLACTIN= 16.4 NG/ML; MONOMERIC PROLACTIN= 4.6NG/ML. ON (B)(6) 2015=57.04 NG/ML, ON (B)(6) 2015=93.82 NG/ML, ON (B)(6) 2015=29.19 NG/ML, ON (B)(6) 2015= 43.92 NG/ML, ON (B)(6) 2015=7.36 NG/ML, ON (B)(6) 2016=12.82, ON (B)(6) 2016=62.82 NG/ML, ON (B)(6) 2016=5.59 NG/ML, ON (B)(6) 2017= 4.62 NG/ML, ON (B)(6) 2017=7.77 NG/ML, ON (B)(6) 2018=28.43 NG/ML, (B)(6) 2018 =25.89 NG/ML, (B)(6) 2018=71.71 NG/ML, ON (B)(6) 2018 AT QUEST. TOTAL PROLACTIN= 16.4 NG/ML; PROLACTIN,MONOMERIC=4.6 NG/ML. PATIENT 2: 64YRS OLD MALE: ARCHITECT PROLACTIN RESULT ON (B)(6) 2023 ARCHITECT PROLACTIN RESULT= 23.0 NG/ML /SENT SAMPLE TO QUEST RESULTS: TOTAL PROLACTIN= 15.4 NG/ML; MONOMERIC PROLACTIN= 9.0 NG/ML, ON (B)(6) 2023= 24.4 NG/ML. SENT SAMPLE TO QUEST. RESULTS: TOTAL PROLACTIN= 11.2; MONOMERIC PROLACTIN= 5.2NG/ML. PREVIOUS HISTORY: ON (B)(6) 2022=20.2 H NG/ML LABORATORY REFERENCE RANGE FOR ABBOTT PROLACTIN= MALE; 3-19 NG/ML; QUEST TOTAL PROLACTIN=2.0 TO 18 NG/ML; MONOMERIC PROLACTIN=3.4 TO 14.8 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279233 ARCHITECT PROLACTIN REAGENT KIT RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) CFT ABBOTT IRELAND DIAGNOSTICS DIVISION 45111UD00 00380740014865

    Patients

    Seq Age Sex Outcome Treatment
    1 Male ARC I2000SR INST, 03M74-02, (B)(6) | ARC I2000SR INST, 03M74-02, (B)(6)