MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR RUBELLA 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	09/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from the united states contacted siemens on 2023-09-05 due to observations of imprecision in calibration and quality control (qc) results for advia centaur rubella g (rub g), lot 246.Specifically, the customer noted imprecision for the level-1 control and repeatedly high cvs for calibration.Siemens service undertook troubleshooting with the customer, including a precision study.Service was sent to the customer site to perform checks and decontamination.Following the service intervention, the customer ran qc with acceptable results before and after successfully recalibrating the assay successfully on 2023-09-19.Patient samples were tested the same day, and one sample was observed to have produced an elevated (positive) rub g result which was discordant relative to alternate-method testing.Siemens was informed of the discordant observation on 2023-09-21.Siemens is investigating.
Event or Problem Description
The customer reported observation of a positive advia centaur rubella g (rub g) result which was discordant relative to alternate-method testing.The initial elevated result was not reported to the physician.The sample was sent to an external reference lab, and a negative result was returned.This result was accepted as correct.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.
Additional Manufacturer Narrative
Mdr 2432235-2023-00261 was initially submitted on 27-sep-2023.Update, sep-2024: siemens has concluded investigation.A customer from the united states reported observation of a reactive advia centaur rub g result which was discordant relative to alternate-method testing.The customer observed imprecision in quality control (qc) results and identified a falsely reactive (false positive) advia centaur rub g result.No other discordant results were identified.Following these observations, service was dispatched, and a comprehensive instrument maintenance procedure was undertaken.Multiple instrument parts were replaced, and a system decontamination was performed.Following the service interventions, the observed issues were resolved.No other discordant observations were reported.The customer is operational, and the observed issue was resolved through routine service intervention.No product problems were identified.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ADVIA CENTAUR RUBELLA G
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA ; 5082985306
• MDR Report Key: 17831088
• Report Number: 2432235-2023-00261
• Device Sequence Number: 6759590
• Product Code: LFX
• UDI-Device Identifier: 00630414201412
• UDI-Public: 00630414201412
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: 03/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 10310283
• Device Lot Number: 246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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 Age: 24 YR
• Patient Sex: Female