MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP RUBELLA G (RUB G) ASSAY; RUBELLA G IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the non-reproduced discordant advia centaur xp rubella g (rub g) result obtained on a patient sample cannot be determined.The customer's rubella g calibration and quality control (qc) were acceptable, and the sample dispense well was clear.Pre-analytical factors cannot be ruled out, and variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.There were no other similar complaints for rubella g reagent lot 068204 on review.Based on the available information, rubella igg lot 068204 is performing as intended.The instruction for use (ifu) under the interpretation of results states the following: "samples with a calculated value of less than 5.0 iu/ml are considered negative for igg antibodies to rubella virus." "samples with a calculated value greater than or equal to 5.0 iu/ml and less than or equal to 9.9 iu/ml are considered equivocal for igg antibodies to rubella virus.Obtain a new specimen and test using the advia centaur rubella g assay." "samples with a calculated value greater than or equal to 10.0 iu/ml are considered positive for igg antibodies to rubella virus." the instrument is performing within specification.No further evaluation of the device is required.
Event or Problem Description
A false positive advia centaur xp rubella g (rub g) result was obtained on a patient sample, and the result was questioned by the physician based on the patient's negative rubella g test history.A second sample was tested by the customer, and the rubella g result was equivocal.The original sample was retested, and the rubella g result was equivocal.A corrected report was issued by the customer.There are no reports that treatment was altered or prescribed or adverse health consequences due to the positive advia centaur xp rubella igg result.

• Brand Name: ADVIA CENTAUR XP RUBELLA G (RUB G) ASSAY
• Common Device Name: RUBELLA G IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7947990
• Report Number: 1219913-2018-00248
• Device Sequence Number: 930278
• Product Code: LFX
• UDI-Device Identifier: 00630414201412
• UDI-Public: 00630414201412
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K003412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2018

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: 03/08/2019
• Device Model Number: N/A
• Device Catalogue Number: 10310283
• Device Lot Number: 068204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR