BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH REAGENT KIT

    MDR report key: 21642917 · Received March 19, 2025

    Report

    Report Number
    3002809144-2025-00098
    Event Type
    Malfunction
    Date Received
    March 19, 2025
    Date of Event
    February 27, 2025
    Report Date
    March 19, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    CEW
    UDI-DI
    00380740156138
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08K25-28 ( THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08K25-29, WITH 510K/PMA/BLA NUMBER K063232. THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ARCHITECT INTACT PTH RESULTS 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 FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. REVIEW OF ALL THE INFORMATION PROVIDED BY THE CUSTOMER WAS REVIEWED. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINTS FOR LIST NUMBER 8K25, HOWEVER, AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 01824B000 WAS NOT IDENTIFIED. THE DEVICE HISTORY RECORD REVIEW FOR LOT 01824B000 DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. THE OVERALL PERFORMANCE OF ARCHITECT INTACT PTH REAGENTS WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 01824B000 ARE WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR LOT 01824B000. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT INTACT PTH REAGENT KIT FOR LOT NUMBER 01824B000 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT INTACT PTH RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A 30-YEAR-OLD FEMALE PATIENT. THE PHYSICIAN IS QUESTIONING THE INCREASED INTACT PTH RESULT 3 MONTHS AFTER HAVING A SUBTOTAL PARATHYROIDECTOMY. (CUSTOMER PROVIDED REFERENCE RANGE 15.0-68.3 PG/ML). THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2024 RESULT = 1633.5 PG/ML. ON (B)(6) 2024 RESULT = 1600.2 PG/ML. RESULTS AFTER SUBTOTAL PARATHYROIDECTOMY: ON (B)(6) 2024 RESULT = 564.3 PG/ML, ON (B)(6) 2024 RESULT = 333.2 PG/ML, ON (B)(6) 2024 RESULT = 451.9 PG/ML, ON (B)(6) 2025 RESULT = 1586.8 PG/ML, REPEAT RESULT = 1575.4 PG/ML. ADDITIONAL LAB RESULTS PROVIDED FROM (B)(6) 2025: GLUCOSE 87 MG/DL, BUN 51.8 MG/DL, CREATININE 10.09 MG/DL, EGFR 4.6 ML/MIN/1.73 M^2, LDL CHOLESTEROL 115 MG/DL, ALBUMIN 4.4 G/DL, SODIUM 138 MMOL/L, POTASSIUM 3.9 MMOL/L, CHLORIDE 96 MMOL/L, CO2 28 MMOL/L, CALCIUM 9.3 MG/DL, PHOSPHORUS 4.9 MG/DL, IRON 57 UG/DL, %IRON SAT 23%, TIBC 247 UG/DL, UIBC 190 UG/DL THE PATIENT HISTORY WAS PROVIDED AND INCLUDES END STAGE RENAL DISEASE (ESRD), HYPERTENSION, HYPERLIPIDEMIA, EXTRACORPOREAL DIALYSIS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689474 ARCHITECT IPTH REAGENT KIT RADIOIMMUNOASSAY, PARATHYROID HORMONE CEW ABBOTT GMBH 01824B000 00380740156138

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female ARC I2000SR INST, 03M74-02, (B)(6)