BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 PROGESTERONE

    MDR report key: 5800078 · Received July 16, 2016

    Report

    Report Number
    2432235-2016-00394
    Event Type
    Malfunction
    Date Received
    July 16, 2016
    Date of Event
    June 19, 2016
    Report Date
    August 5, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    JLS
    PMA / PMN Number
    K944211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2016-00394 WAS FILED ON JULY 15, 2016. ADDITIONAL INFORMATION (07/25/2016): INFORMATION REGARDING REAGENT LOT # FOR IMMULITE 2000 XPI PROGESTERONE WAS RECEIVED. THE REAGENT LOT # IS 457 AND HAS BEEN AMENDED WITH THIS INFORMATION. ADDITIONAL INFORMATION (07/28/2016): A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE DATA PROVIDED BY THE CUSTOMER AND INDICATED THAT DIFFERENT ANTIBODIES ARE USED TO CREATE PROGESTERONE ASSAY. ADVIA CENTAUR XP USES MOUSE MONOCLONAL AND IMMULITE 2000 XPI USES RABBIT POLYCLONAL ANTIBODIES, AND THEREFORE THEY CAN SHOW DIFFERENT CROSS REACTIVITY. THE PATIENT SAMPLES, MEDICATIONS OR TREATMENT WERE NOT PROVIDED FOR FURTHER INVESTIGATION OR TO RULE OUT CROSS REACTIVITY. IMMUNOASSAYS CAN BE SUBJECT TO A NUMBER OF INTERFERENCES INCLUDING EXOGENOUS INTERFERENCES SUCH AS DRUGS, NUTRITIONAL SUPPLEMENTS AND/OR HERBAL MEDICINE IN THE BLOOD. THE HSC SPECIALIST REVIEWED THE QUALITY CONTROL DATA AND INDICATED THAT THE QUALITY CONTROLS WERE ACCEPTABLE INDICATING THAT THE ASSAY IS PERFORMING AS EXPECTED.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCORDANT, FALSELY LOW PROGESTERONE RESULTS ON ONE PATIENT IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW IMMULITE 2000 XPI PROGESTERONE RESULTS WERE OBTAINED WHEN COMPARING TWO SAMPLES DRAWN FROM THE SAME PATIENT WITHIN A FEW HOURS OF ONE ANOTHER. SAMPLE ID (B)(6) WAS INITIALLY TESTED ON AN ALTERNATE CUSTOMER SITE AND THE RESULTS OBTAINED ON ADVIA CENTAUR XP AND IMMULITE 2000 XPI INSTRUMENTS DID NOT MATCH. ONE OF THE RESULTS OBTAINED ON ADVIA CENTAUR XP INSTRUMENT WAS REPORTED TO THE PHYSICIAN(S). A DIFFERENT SAMPLE WAS DRAWN FROM THE PATIENT A FEW HOURS LATER AT THIS CUSTOMER SITE. THIS SAMPLE WAS RUN ON THE IMMULITE 2000 XPI AND ADVIA CENTAUR XP INSTRUMENTS AND THE RESULTS STILL DID NOT MATCH. IT IS UNKNOWN WHICH RESULTS WERE CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW PROGESTERONE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454852 IMMULITE 2000 PROGESTERONE IMMULITE 2000 PROGESTERONE JLS SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 PROGESTERONE 457

    Patients

    Seq Age Sex Outcome Treatment
    1