BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGF-1

    MDR report key: 15729514 · Received November 4, 2022

    Report

    Report Number
    1823260-2022-03489
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    August 23, 2022
    Report Date
    March 8, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFL
    UDI-DI
    07613336140864
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ALIQUOT OF THE PATIENT SAMPLE INITIALLY REPORTED WAS PROVIDED FOR INVESTIGATION. THE INVESTIGATION OBTAINED A ROCHE IGF-1 RESULT OF 94 NMOL/L AND A SIEMENS IMMULITE RESULT OF 52 NMOL/L. THE SAMPLE WAS TESTED USING A DIASORIN ANALYZER FOR IGF-1. THE RESULT WAS 607.2 NG/ML (79.4 NMOL/L). THE DIASORIN REFERENCE RANGE FOR THIS PATIENT IS 83 - 519 NG/ML (10.9 - 67.9 NMOL/L). THIS PATIENT WAS ALSO REPORTED TO BE TAKING NORDITROPIN (SOMATROPIN). PER PRODUCT LABELING, "... THE FOLLOWING SPECIAL GROWTH DISORDER DRUGS WERE TESTED. NO INTERFERENCE WITH THE ASSAY WAS FOUND: SOMATROPIN - 3.0 MG/L CONCENTRATION." TWO ADDITIONAL SAMPLES FROM A SECOND PATIENT WERE ALSO SENT FOR INVESTIGATION. PATIENT 2 IS MALE, 15 YEARS OLD. THE INVESTIGATION OBTAINED A ROCHE IGF-1 RESULT OF 46 NMOL/L AND A SIEMENS IMMULITE RESULT OF 29 NMOL/L FROM THE FIRST SAMPLE. THE INVESTIGATION OBTAINED A ROCHE IGF-1 RESULT OF 59 NMOL/L AND A SIEMENS IMMULITE RESULT OF 39 NMOL/L FROM THE SECOND SAMPLE. THE ROCHE REFERENCE RANGE FOR PATIENT 2 IS 16 - 65 NMOL/L. THE SIEMENS REFERENCE RANGE WAS REQUESTED BUT NOT PROVIDED. PATIENT 2'S SECOND SAMPLE WAS TESTED USING A DIASORIN ANALYZER AND THE RESULT WAS 446.0 NG/ML (58.3 NMOL/L). THE DIASORIN REFERENCE RANGE FOR PATIENT 2 IS 102-520 NG/ML (13.3 - 67.9 NMOL/L). THE INVESTIGATION CONFIRMED THE RECOVERY OF THE ELECSYS IGF-1 ASSAY WITH ANOTHER COMPETITOR METHOD AND THE WHO STANDARD. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS IGF-1 ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MODULE COMPARED TO A SIEMENS IMMULITE. ON (B)(6) 2022, THE IGF-1 RESULT WAS 89 NMOL/L. ON (B)(6) 2022, THE SIEMENS IGF-1 RESULT WAS 60 NMOL/L. THE EXACT DATE OF TESTING WAS REQUESTED BUT NOT PROVIDED. ON (B)(6) 2022, THE SAMPLE WAS REPEATED ON THE E801 MODULE AND THE RESULT WAS 94 NMOL/L. THE ROCHE REFERENCE RANGE IS 15 - 64 NMOL/L. THE SIEMENS REFERENCE RANGE IS 23 - 66 NMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E801 MODULE SERIAL NUMBER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2784365 ELECSYS IGF-1 RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE CFL ROCHE DIAGNOSTICS NA 61446801 07613336140864

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male GROWTH HORMONE| NORDITROPIN (PATIENT 1)