BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS C-PEPTIDE

    MDR report key: 12342278 · Received August 19, 2021

    Report

    Report Number
    1823260-2021-02416
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 22, 2021
    Report Date
    November 24, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JKD
    UDI-DI
    04015630939992
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B7 WAS UPDATED.

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE ACCEPTABLE. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION WHERE THE RESULTS WERE SIMILAR TO THE CUSTOMER'S RESULTS: C-PEPTIDE: 37.21 NG/ML. INSULIN: 1478 UU/ML. THE SAMPLE WAS TREATED WITH HETEROPHILIC BLOCKING TUBE (HBT): C-PEPTIDE: 37.58 NG/ML. INSULIN: 1478 UU/ML. THE SAMPLE WAS TREATED BY PRECIPITATION BY POLYETHYLENE GLYCOL (PEG): INSULIN: 295 UU/ML. BASED ON THE INVESTIGATION RESULTS, AN INTERFERING FACTOR WAS NOT IDENTIFIED. THE LOWER INSULIN RESULT AFTER PEG TREATMENT INDICATE AUTO-ANTI INSULIN ANTIBODIES IN THE SAMPLE. BASED ON THE QUALITY VALIDATION DATA, A GENERAL INSULIN AND C-PEPTIDE REAGENT ISSUE CAN BE EXCLUDED. THE HIGHER ROCHE INSULIN RESULTS ARE CONSISTENT WITH THE PRESENCE OF ANTI-INSULIN ANTIBODIES WHICH WERE RECOGNIZED BY THE ASSAY. THE DIFFERENT C-PEPTIDE RESULTS BETWEEN ROCHE AND BECKMAN ARE DUE TO DIFFERENT METHODS USED BY THE RESPECTIVE MANUFACTURER. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TREATED AND TESTED THE SAMPLE BY PRECIPITATION BY POLYETHYLENE GLYCOL (PEG) ON THE E801 MODULE. THE INSULIN RESULT AFTER PEG TREATMENT WAS 125 UU/ML. THE C-PEPTIDE RESULT AFTER PEG TREATMENT WAS 4.04 NG/ML. THE CUSTOMER ALSO PERFORMED A DILUTION EXPERIMENT ON THE E801 MODULE: C-PEPTIDE WITH 1:2 DILUTION WAS 21.1 NG/ML; FINAL RESULT WAS 42.2 NG/ML. C-PEPTIDE WITH 1:4 DILUTION WAS 12.1 NG/ML; FINAL RESULT WAS 48.4 NG/ML. C-PEPTIDE WITH 1:16 DILUTION WAS 4.80 NG/ML; FINAL RESULT WAS 76.8 NG/ML. INSULIN WITH 1:16 DILUTION WAS 105 UU/ML; FINAL RESULT WAS 1680 UU/ML. THE SAMPLE WAS REQUESTED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS INSULIN (INSULIN) AND ELECSYS C-PEPTIDE (C-PEPTIDE) ON A COBAS E801 MODULE COMPARED TO THE BECKMAN METHOD. THIS MEDWATCH WILL COVER C-PEPTIDE. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER PT-59788 FOR INFORMATION ON THE INSULIN RESULTS. THE INITIAL INSULIN RESULT FROM THE E801 MODULE WAS 1000 UU/ML WITH A DATA FLAG. THE INITIAL C-PEPTIDE RESULT FROM THE E801 MODULE WAS 34.9 NG/ML. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THEY WERE QUESTIONED BY THE DOCTOR. ON (B)(6) 2021 THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY USING THE BECKMAN METHOD AND THE INSULIN RESULT WAS 136.13 UU/ML AND THE C-PEPTIDE RESULT WAS 20.35 NG/ML. THE CUSTOMER DOES NOT KNOW WHICH RESULTS ARE CORRECT AND SUSPECTS AN INTERFERENCE. THE E801 MODULE SERIAL NUMBER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241210 ELECSYS C-PEPTIDE C-PEPTIDE IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY JKD ROCHE DIAGNOSTICS NA 51737001 04015630939992

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male