BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 PROGESTERONE

    MDR report key: 12378791 · Received August 27, 2021

    Report

    Report Number
    1219913-2021-00437
    Event Type
    Malfunction
    Date Received
    August 27, 2021
    Date of Event
    July 29, 2021
    Report Date
    November 17, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    JLS
    UDI-DI
    00630414961989
    PMA / PMN Number
    K944211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HEALTHCARE DIAGNOSTICS FILED MDR 1219913-2021-00437 INITIAL REPORT ON 2021-08-27. ADDITIONAL INFORMATION - 2021-11-05. BECAUSE THE AFFECTED PATIENT SAMPLE WAS NOT AVAILABLE FOR SIEMENS TO TEST FOR FURTHER INVESTIGATION, THE CUSTOMER PROVIDED A SAMPLE FROM A DIFFERENT PATIENT ALSO UNDERGOING IN-VITRO FERTILIZATION. SIEMENS TESTED THIS RETURNED PATIENT SAMPLE FOR PROGESTERONE ON THE IMMULITE 2000 (LOTS 577 & 578) AND ON THE ATELLICA IM. RESULTS WERE AS FOLLOWS: IMMULITE 2000 LOT 577 = 1.27 NG/ML, IMMULITE 2000 LOT 578= 1.36 NG/ML ATELLICA IM= 0.85 NG/ML. ADDITIONAL INFORMATION - 2021-11-15. SIEMENS HAS CONCLUDED THE INVESTIGATION FOR AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER REGARDING A FALSELY ELEVATED IMMULITE 2000 PROGESTERONE (PRG) RESULT COMPARED TO THE LOWER RESULT OBTAINED ON A NON-SIEMENS ALTERNATE METHOD. THE IMMULITE 2000 PRG RESULT WAS 1.3 NG/ML AND THE NON-SIEMENS ALTERNATE METHOD RESULT WAS 0.3 NG/ML. THIS PATIENT IS UNDERGOING IN-VITRO FERTILIZATION. QUALITY CONTROL WAS NOT AFFECTED. THIS PATIENT SAMPLE WAS NOT AVAILABLE FOR SIEMENS TO TEST. THE CUSTOMER PROVIDED A SAMPLE FROM A DIFFERENT PATIENT ALSO UNDERGOING IN-VITRO FERTILIZATION. THIS PATIENT SAMPLE WAS TESTED FOR PROGESTERONE ON THE IMMULITE 2000 (LOTS 577 & 578) AND ON THE ATELLICA IM. RESULTS WERE AS FOLLOWS: IMMULITE 2000 LOT 577 = 1.27 NG/ML, IMMULITE 2000 LOT 578= 1.36 NG/ML ATELLICA IM= 0.85 NG/ML. PROGESTERONE RESULTS BETWEEN DIFFERENT PLATFORMS MAY NOT BE INTERCHANGEABLE, AS EVIDENCED BY THE DIFFERENT RESULTS OBTAINED BETWEEN THE IMMULITE 2000 AND ATELLICA IM INSTRUMENTS AND THE DIFFERENT REFERENCE RANGES LISTED IN THEIR RESPECTIVE INSTRUCTIONS FOR USE. A FALSELY ELEVATED OR DEPRESSED PROGESTERONE MAY AFFECT IVF TREATMENT DECISIONS, HOWEVER THE POTENTIAL IS MITIGATED DUE TO CORRELATION WITH OTHER HORMONE MARKERS FOR DIAGNOSIS. A POTENTIAL PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED DURING THIS INVESTIGATION. THE CUSTOMER IS OPERATIONAL. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION TYPE, FINDING, AND CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

    SIEMENS IS INVESTIGATING. THE LIMITATIONS SECTION IN THE ASSAY INSTRUCTIONS FOR USE STATES: "HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH THE IMMUNOGLOBULINS INCLUDED IN THE ASSAY COMPONENTS CAUSING INTERFERENCE WITH IN VITRO IMMUNOASSAYS. SAMPLES FROM PATIENTS ROUTINELY EXPOSED TO ANIMALS OR ANIMAL SERUM PRODUCTS CAN DEMONSTRATE THIS TYPE OF INTERFERENCE POTENTIALLY CAUSING AN ANOMALOUS RESULT. THESE REAGENTS HAVE BEEN FORMULATED TO MINIMIZE THE RISK OF INTERFERENCE; HOWEVER, POTENTIAL INTERACTIONS BETWEEN RARE SERA AND TEST COMPONENTS CAN OCCUR." "WITH THE ADVENT OF NEW STEROID BASED MEDICATIONS (ANALOGUES) WITH SIMILAR CHEMICAL STRUCTURES TO PROGESTERONE, THERE IS THE POSSIBILITY OF CROSS-REACTIVITY AND FALSELY ELEVATED RESULTS. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS. IF THE PROGESTERONE RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT."

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A FALSELY ELEVATED IMMULITE 2000 PROGESTERONE RESULT FOR AN IN-VITRO FERTILIZATION (IVF) PATIENT. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAMPLE WAS RETESTED WITH AN ALTERNATE METHOD IN A DIFFERENT LABORATORY AND A LOWER RESULT WAS OBTAINED. THE CUSTOMER STATES THAT IVF TREATMENT WAS WITHHELD DUE TO FALSE ELEVATED PROGESTERONE RESULTS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED IMMULITE 2000 PROGESTERONE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274577 IMMULITE 2000 PROGESTERONE PROGESTERONE IMMUNOASSAY JLS SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED N/A 576 00630414961989

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female