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	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of reactive (positive) advia centaur rubella g (rub g) results which were discordant relative to alternate-method testing.Variable calibration slope was observed in association with the discordant observations.Siemens is investigating.
Event or Problem Description
The customer reports observation of reactive (positive) advia centaur rubella g (rub g) results which were discordant relative to alternate-method testing when using rub g lot 251.The customer noticed a change in slope (from a high near 1.6 to a lower value close to 1.0) and a shift in quality control (qc) results when the rub g assay was recalibrated.Samples which had been run when the slope was higher were repeat-tested when the slope was closer to 1.0.Six (6) samples were re-tested using the same analyzer.Repeat results for these samples were lower, with one initially reactive sample producing an equivocal result upon repeat; no clinical discordance was identified.The customer was uncomfortable with the observed variation in slope for the rub g reagent lot, and ceased use of the advia centaur rub g assay.Additional samples were sent for re-test to an external laboratory, where an alternate method was used.These 11 samples produced lower results when re-tested using the alternate method; two samples which had initially produced reactive advia centaur rub g results produced nonreactive (negative) results upon re-test.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed result discordance.
Additional Manufacturer Narrative
Mdr 1219913-2024-00461 was initially filed on 05-nov-2024.Update on 19-dec-2024: siemens has concluded incident investigation.A customer from outside the united states reported observation of reactive (positive) advia centaur rubella g (rub g) results which were discordant relative to alternate-method testing.It was noted that the calibration for the rub g assay had demonstrated an unusually high slope, although the observed slope met acceptance criteria.Quality control (qc) results were biased low, which is attributable to the fact that the customer was not using the recommended qc lot for this particular assay reagent lot.When the customer recalibrated the assay a few days later, the observed signal levels and slope were similar to assay-release data and historical performance.No other false-positive observations were reported following recalibration.The discordant observations are most likely attributable to the aberrant calibration in use at the time; the cause for the calibration issue could not be specifically identified.Multiple factors can affect a calibration, including reagent-pack-specific issues, the calibrator material used, as well as operator handling and system components.No product problem was identified.The customer is operational, and the isolated issue was resolved by routine troubleshooting; no further action is required.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 ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney st.; registration no. 1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 20612912
• Report Number: 1219913-2024-00461
• Device Sequence Number: 7553054
• Product Code: LFX
• UDI-Device Identifier: 00630414201412
• UDI-Public: (01)00630414201412(10)73267251(17)250313
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 12/19/2024

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: 03/13/2025
• Device Model Number: N/A
• Device Catalogue Number: 10310283
• Device Lot Number: 73267251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2024
• 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: Unknown