BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS PROLACTIN ASSAY

    MDR report key: 11388436 · Received February 26, 2021

    Report

    Report Number
    1823260-2021-00602
    Event Type
    Malfunction
    Date Received
    February 26, 2021
    Date of Event
    February 4, 2021
    Report Date
    May 4, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFT
    PMA / PMN Number
    K964748
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE WITHIN SPECIFICATIONS. THE CUSTOMER CORRECTLY PRETREATED THE SAMPLES WITH PEG (POLYETHYLENE GLYCOL) PRIOR TO TESTING. TESTING RESULTS: (LISTED AS: PATIENT ID: PRL II+PEG (NG/ML), PRL II/C, PEG/C). 2: 33, 149%, 112%. 3: 32, 143%,119%. 4: 37.8, 172%, 147%. 5: 28.2, 136%, 107%. 6: 33.4, 139%, 121%. 7: 26.6, 150%, 121%. 8: 38.4, 141%, 139%. 9: 24.8, 152%, 119%. 14: 19.76, 132%, 101%. 15: 22.4, 133%, 114%. 17: 19.36, 154%, 127%. 18: 29.4, 178%, 154%. 19: 22, 131%, 100%. 20: 31.8, 147%, 123%. 21: 27, 131%, 76%. 22: 40.6, 139%, 96%. 23: 18.3, 146%, 90%. 24: 27.2, 173%, 145%. 26: 57.4, 144%, 121%. 27: 25.2, 141%, 129%. 29: 17.48, 144%, 107%. 31: 19.32, 151%, 131%. 32: 15.14, 172%, 123%. THE INVESTIGATION FOUND THAT THE SAMPLES ARE SUSPICIOUS OF CONTAINING HIGH AMOUNTS OF MACRO PROLACTIN, FOR WHICH THE ELECSYS PRL II ASSAY IS MORE SENSITIVE THAN THE CENTAUR/SEIMENS PLATFORM. THE CUSTOMER PRE-SELECTED SPECIAL PATIENT SAMPLES AND COMPARED THOSE TO A COMPETITOR ASSAY. THIS IS SUGGESTED BY HIGH FREQUENCY OF > REFERENCE RANGE SAMPLES WITH LOW POST-PEG PRL II RECOVERY THE INVESTIGATION CONCLUDED THE MEASURED VALUES ARE CORRECT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI) # (B)(4). (B)(6). THIS EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS PROLACTIN ASSAY RESULTS WITH 23 PATIENT SAMPLES ON A 8000 E 801 MODULE, SERIAL NUMBER (B)(4). REFER TO ATTACHMENT "(B)(6)" FOR PATIENT RESULTS. THE ROCHE RESULTS WERE QUESTIONED AS THEY WERE INCOMPATIBLE WITH THE PATIENTS' CLINICAL PICTURE AND REPEAT TESTING BY THE SIEMENS CENTAUR METHOD WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283177 ELECSYS PROLACTIN ASSAY RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) CFT ROCHE DIAGNOSTICS NA 48264802

    Patients

    Seq Age Sex Outcome Treatment
    1