BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGF-1

    MDR report key: 15117092 · Received July 27, 2022

    Report

    Report Number
    1823260-2022-02210
    Event Type
    Malfunction
    Date Received
    July 27, 2022
    Date of Event
    February 13, 2020
    Report Date
    September 29, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFL
    UDI-DI
    07613336143131
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELD "D4 - LOT NO" WAS UPDATED.

    Additional Manufacturer Narrative · 0

    THE PATIENT SAMPLES WERE RECEIVED FOR INVESTIGATION. THE INVESTIGATION DETERMINED THAT THE SAMPLES DID NOT SHOW EXTREMELY HIGH VALUES BUT WERE IN THE RANGE OF 145 - 575 NG/ML. THE CUSTOMER'S REPORTED RESULT OF 858.5 NG/ML WAS NOT OBSERVED IN THE RESULTS OBTAINED BY THE INVESTIGATION. THE HIGHEST MEASURED RESULT WAS 575.6 NG/ML. THE INVESTIGATION WAS UNABLE TO CONFIRM THE CUSTOMER'S COMPLAINT. THE CALIBRATION, QC AND INSTRUMENT DATA WERE REQUESTED BUT NOT PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS IGF-1 RESULTS FOR 18 PATIENTS TESTED WITH A COBAS E411 DISK. BASED ON THE PROVIDED DATA, THE IGF RESULTS FOR SIX PATIENTS WERE DISCREPANT. PRIOR TO PATIENT TESTING, THE CUSTOMER CONFIRMS THAT CALIBRATION AND QC HAVE BEEN ACCEPTABLE. THE ELECSYS IGF RESULTS WERE REPORTED OUTSIDE THE LABORATORY. DUE TO THE RESULTS NOT MATCHING THE CLINICAL PICTURE OF THE PATIENTS, THE PATIENTS HAVE A NEW SAMPLE COLLECTED AND TESTED AT A DIFFERENT LABORATORY AND WITH A SIEMENS IMMULITE 2000. THE CUSTOMER DETERMINED THE SIEMENS RESULTS WERE CORRECT. SAMPLE IDENTIFIER (B)(6) HAD AN ELECSYS IGF RESULT OF 204.8 NG/ML. THE PATIENT'S SIEMENS IMMULITE IGF RESULT WAS 149 NG/ML. SAMPLE IDENTIFIER (B)(6) HAD AN ELECSYS IGF RESULT OF 699.5 NG/ML. THE PATIENT'S SIEMENS IMMULITE IGF RESULT WAS 517 NG/ML. SAMPLE IDENTIFIER (B)(6) HAD AN ELECSYS IGF RESULT OF 553.3 NG/ML. THE PATIENT'S SIEMENS IMMULITE IGF RESULT WAS 411 NG/ML. SAMPLE IDENTIFIER (B)(6) HAD AN ELECSYS IGF RESULT OF 395.4 NG/ML. THE PATIENT'S SIEMENS IMMULITE IGF RESULT WAS 297 NG/ML. SAMPLE IDENTIFIER (B)(6) HAD AN ELECSYS IGF RESULT OF 858.5 NG/ML. THE PATIENT'S SIEMENS IMMULITE IGF RESULT WAS 607 NG/ML. SAMPLE IDENTIFIER (B)(6) HAD AN ELECSYS IGF RESULT OF 883.3 NG/ML. THE PATIENT'S SIEMENS IMMULITE IGF RESULT WAS 671 NG/ML. THE E411 SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117155 ELECSYS IGF-1 HUMAN GROWTH HORMONE ASSAY CFL ROCHE DIAGNOSTICS IGF-1 61445601 07613336143131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown