BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I INTACT PTH REAGENT KIT

    MDR report key: 12780911 · Received November 9, 2021

    Report

    Report Number
    3002809144-2021-00640
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 28, 2021
    Report Date
    March 1, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    CEW
    PMA / PMN Number
    K063232
    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.

    Additional Manufacturer Narrative · 0

    A TICKET SEARCH FOR LOT 00845L821 DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE FALSELY ELEVATED PATIENT RESULTS. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 00845L821, WHICH DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. HISTORICAL PERFORMANCE OF REAGENT LOT 00844L821, WHICH IS A SISTER-LOT OF THE LIKELY CAUSE LOT 00845L821, WAS REVIEWED USING WORLDWIDE FIELD DATA. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 00844L821 WAS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR LOT 00844L821. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I SERIES CONCENTRATED WASH BUFFER WAS IDENTIFIED IN THE COMPLAINT.CORRECTED DATA FOUND IN SECTION G1. MANUFACTURER CONTACT OFFICE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I INTACT PTH RESULTS AFTER SWITCHING FROM ROCHE TO THE ALINITY. THE PHYSICIAN WAS SKEPTICAL ABOUT THE ALINITY RESULTS AND ADDITIONAL SEROLOGICAL TESTS WERE ORDERED. THE FOLLOWING DATA WAS PROVIDED (ALINITY IPTH REFERENCE RANGE 15.0 TO 68.3 PG/ML; ROCHE IPTH REFERENCE RANGE 15.0 TO 65.0 PG/ML): ALINITY RESULT 99.3, ROCHE RESULT 18.11. ALINITY RESULT 101.2, ROCHE RESULT 25.85. ALINITY RESULT 90.6, ROCHE RESULT 34.18. ALINITY RESULT 28.9, ROCHE RESULT 45.31. ALINITY RESULT 191, ROCHE RESULT 56.08. ALINITY RESULT 137, ROCHE RESULT 101. ALINITY RESULT 170, ROCHE RESULT 102. ALINITY RESULT 170.8, ROCHE RESULT 115.1. ALINITY RESULT 64.2, ROCHE RESULT 127.8. ALINITY RESULT 436, ROCHE RESULT 152. ALINITY RESULT 309.7, ROCHE RESULT 152.9. ALINITY RESULT 253.5, ROCHE RESULT 159.1. ALINITY RESULT 242.2, ROCHE RESULT 181.7. ALINITY RESULT 425.3, ROCHE RESULT 205.1. ALINITY RESULT 301.7, ROCHE RESULT 205.4. ALINITY RESULT 310.6, ROCHE RESULT 215.3. ALINITY RESULT 430, ROCHE RESULT 228.6. ALINITY RESULT 386.6, ROCHE RESULT 232.5. ALINITY RESULT 395, ROCHE RESULT 247. ALINITY RESULT 523.4, ROCHE RESULT 255. ALINITY RESULT 480.7, ROCHE RESULT 268.7. ALINITY RESULT 151.5, ROCHE RESULT 270. ALINITY RESULT 500, ROCHE RESULT 283. ALINITY RESULT 457.5, ROCHE RESULT 300.3. ALINITY RESULT 592.1, ROCHE RESULT 302.9. ALINITY RESULT 642.8, ROCHE RESULT 366.2. ALINITY RESULT 511.8, ROCHE RESULT 374.1 . ALINITY RESULT 648.4, ROCHE RESULT 410.5. ALINITY RESULT 630.5, ROCHE RESULT 421.8. ALINITY RESULT 727.7, ROCHE RESULT 490.2. ALINITY RESULT 182.5, ROCHE RESULT 519.3. ALINITY RESULT 1103, ROCHE RESULT 681. ALINITY RESULT 996, ROCHE RESULT 708.4. ALINITY RESULT 1348, ROCHE RESULT 1002. ALINITY RESULT 954.8, ROCHE RESULT 1597. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678658 ALINITY I INTACT PTH REAGENT KIT RADIOIMMUNOASSAY, PARATHYROID HORMONE CEW ABBOTT GMBH 00845L821

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)