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

Model Number	N/A
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of negative (nonreactive) atellica im rubella igm (rubm) results which were discordant relative to alternate-method testing.Rubm kit lot 211 was in use at the time.A sample from a pregnant female patient was sent from a related lab for confirmatory testing, following an initial positive rubella igm result.On (b)(6) 2023, this sample was tested using atellica im rubm, and produced a nonreactive (negative) result ¿ in conflict with the initial positive result.The source lab also sent the sample in question to an external reference lab, which confirmed the initial positive result.The positive result was accepted as correct.There are no allegations of patient harm, changes in treatment, or delays of diagnosis due to the observed discordance.The result disagreement was reproduced in later investigational testing.When the customer re-tested the sample using two atellica im instruments on (b)(6) 2023, additional nonreactive rubm results were produced.The sample was additionally tested using another alternate method, and a positive result was obtained.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of negative (nonreactive) atellica im rubella igm (rubm) results which were discordant relative to alternate-method testing.Follow-up testing demonstrated that the discordant nonreactive results were reproducible for this specimen.Quality control (qc) results on the day of the event were within expected ranges.Siemens is investigating.
Additional Manufacturer Narrative
Mdr 1219913-2023-00193 was initially submitted on 2023-09-14.A customer from outside the united states reported observation of negative (nonreactive) atellica im rubella igm (rub m) results which were discordant relative to alternate-method testing.Update, 2023 (b)(6) : siemens has concluded the investigation.The sample was repeat-tested twice using the same atellica im rub m reagents on two atellica im analyzers, and the negative result was reproducible.No other tests were performed on this patient.Assay calibration was valid and quality control (qc) results were within expected ranges.Siemens reviewed internal data and determined that rub m lot 211 met all release criteria and was comparable to other reagent lots.No other complaints have been received regarding false-negative rub m results.There is insufficient remaining sample to permit additional testing by siemens.While there is insufficient information to definitively determine the cause of the reproducible false negative rub m results for this patient, the probable cause is a patient-specific assay interferent.The customer is operational.No product problem was identified.Note: in section h6, the codes for investigation findings and investigation conclusion have been updated.

• Brand Name: ATELLICA IM RUBELLA IGM (RUBM)
• 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.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 17757172
• Report Number: 1219913-2023-00193
• Device Sequence Number: 12425645
• Product Code: LFX
• UDI-Device Identifier: 00630414599830
• UDI-Public: 00630414599830
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K010668
• 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): 10/16/2023

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: 02/22/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995668
• Device Lot Number: 211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• 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