MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM RUBELLA IGG (RUB G); ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Model Number	N/A
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of reactive (positive) atellica im rubella igg (rub g) results which were discordant relative to alternate-method testing.The assay¿s instructions for use states the following, under limitations: ¿the drug fulvestrant (faslodex®) may cause falsely elevated estradiol results in immunoassays.For patients being treated with fulvestrant, an alternate method that is not expected to show cross-reactivity to fulvestrant, such as liquid chromatography-mass spectrometry (lc-ms), should be used.¿ ¿with the advent of new steroid-based medications (analogues) with similar chemical structures to estradiol, there is the possibility of cross-reactivity and results inconsistent with the patient's clinical history.For diagnostic purposes, the results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings.If the estradiol results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.¿ ¿patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize interference from heterophilic antibodies.Additional information may be required for diagnosis.¿ siemens is investigating.
Event or Problem Description
The customer reports observation of reactive (positive) atellica im rubella igg (rub g) results which were discordant relative to alternate-method testing.Rub g kit lot 247 was in use at the time.The customer observed reactive rub g results for one patient which were considered falsely positive.The patient in question was initially tested in (b)(6), and produced an equivocal rub g result when tested with atellica im rub g, lot 243.No additional testing is described for that time period.The same patient was tested again in (b)(6), using rub g kit lot 247.The result for this second sample was reactive (positive).As this reactive result was considered questionable, the patient¿s earlier (equivocal) sample from (b)(6) was re-tested to investigate.This sample, which had earlier produced an equivalent result with the earlier kit lot, now gave a reactive result when tested with rub g lot 247, indicating that this patient was reproducibly reactive.Both samples from this patient (b)(6) were sent to an external lab, and tested by an alternate method.Both samples returned negative results.There are no allegations of patient harm in association with the observed discordance.
Additional Manufacturer Narrative
Mdr 1219913-2023-00330 was initially submitted on 2023-12-18.A customer from outside the united states reported observation of reactive (positive) atellica im rubella igg (rub g) results which were discordant relative to alternate-method testing.This patient¿s test result from three months earlier had been equivocal when tested with rub g lot 243.No issues were identified with assay calibration or quality control (qc) results.Siemens reviewed internal release data for rub g kit lot 247, and confirmed that the lot met all applicable criteria.Test samples across the assay range demonstrated result interpretation equivalent to that seen for kit lot 243.Sufficient sample was not available to allow additional testing by siemens.The customer did not test the sample with a heterophilic blocking tube (hbt).Field results for patient samples were reviewed for the period of november 2022 through december 2023, which included data from five reagent lots, including lot 247.Results from rub g lot 247 were found to be distributed similarly to those of the other lots.No systemic result bias was identified.The apparent inconsistency between the earlier equivocal result and later reactive results may be explained by the following note in the assay¿s instructions for use (ifu), under limitations: ¿for patient samples measuring at or around the cut-off value of 10.0¿15.0 iu/ml, significantly elevated or increasing concentrations of total igg may change a positive qualitative interpretation to equivocal or, rarely, may result in a negative interpretation.¿ although a specific cause was identified for the disagreement between test methods, no product performance issue was identified for atellica im rub g.The customer is operational, and no further action is required.Note: in section h6, the codes for type of investigation, investigation findings, and investigation conclusions have been updated.

• Brand Name: ATELLICA IM RUBELLA IGG (RUB G)
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; east walpole 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 18345514
• Report Number: 1219913-2023-00330
• Device Sequence Number: 6222442
• Product Code: LFX
• UDI-Device Identifier: 00630414600529
• UDI-Public: 00630414600529
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K003412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995670
• Device Lot Number: 247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female