BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS PROLACTIN ASSAY

    MDR report key: 11615040 · Received April 5, 2021

    Report

    Report Number
    1823260-2021-01022
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 10, 2021
    Report Date
    May 3, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFT
    PMA / PMN Number
    K964748
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE INITIAL REPORT IT WAS STATED: "THE CUSTOMER PERFORMED POLYETHYLENE GLYCOL (PEG) PRECIPITATION AND THE RESULT FROM THE E801 MODULE WAS 1185 UIU/ML.". CLARIFICATION WAS RECEIVED THAT THIS SHOULD SAY: "THE CUSTOMER PERFORMED POLYETHYLENE GLYCOL (PEG) PRECIPITATION AND THE CALCULATED RESULT FROM THE E801 MODULE USING X2 DILUTION WAS 2370 UIU/ML.". DURING THE INVESTIGATION OF THE PATIENT SAMPLE, THE INITIAL REPORT STATED THE RESULT WITH PEG TREATMENT WAS 1165 UIU/ML. IT WAS CLARIFIED THAT THE INVESTIGATION USED A X2 DILUTION FACTOR AND THE RESULT AFTER CALCULATION WAS 2330 UIU/ML. THE PEG RESULT DURING THE INVESTIGATION CORRESPONDS TO THE CUSTOMER'S PEG RESULT. THE ACTUAL PROLACTIN RESULT FROM THE SIEMENS METHOD WAS PROVIDED: 135.0 UG/L (2862 UIU/ML). THE SIEMENS RESULT AND THE CUSTOMER'S ROCHE RESULT CORRESPOND TO ONE ANOTHER. CALIBRATION AND QC WERE ACCEPTABLE. BASED ON THE INVESTIGATION RESULTS, A GENERAL REAGENT ISSUE WAS NOT IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI): (B)(4). SAMPLE MATERIAL FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION AND TESTED WITH PROLACTIN II REAGENT 482648 ON A COBAS E801 MODULE. THE CUSTOMER¿S RESULTS COULD BE CONFIRMED: SAMPLE RESULT (¿IU/ML): UNTREATED: 3104, + PEG: 1165, + HETEROPHILIC BLOCKING TUBE (HBT): 3075. THE UNTREATED RESULT AND PEG RESULT INDICATE THE PRESENCE OF MACRO PROLACTIN IN THE PATIENT SAMPLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS PROLACTIN II (PROLACTIN II) ON A COBAS E801 MODULE COMPARED TO THE SIEMENS METHOD. THE INITIAL RESULT FROM THE E801 MODULE WAS 3138 UIU/ML (REFERENCE RANGE 102 ¿ 496 UIU/ML). THE CUSTOMER PERFORMED POLYETHYLENE GLYCOL (PEG) PRECIPITATION AND THE RESULT FROM THE E801 MODULE WAS 1185 UIU/ML. THE RESULTS FROM THE E801 MODULE WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE PHYSICIAN QUESTIONED THE RESULTS. THE SAMPLE WAS TESTED BY THE SIEMENS METHOD AND THE RESULT WAS WITHIN THE REFERENCE RANGE (NORMAL UP TO 530 UIU/ML). THE SPECIFIC RESULT WAS NOT PROVIDED. THE PHYSICIAN SUSPECTS AN INTERFERENCE AFFECTING THE ROCHE RESULTS. THE E801 MODULE SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512684 ELECSYS PROLACTIN ASSAY RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) CFT ROCHE DIAGNOSTICS NA 48264801

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR