MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP 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	10/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) was sent to the customer site for system inspection.The cse replaced the base pump, reagent diluter, and reagent syringe valve while troubleshooting, and several samples were run with expected results.The customer has observed additional sample comparison results not matching when run in duplicate (actual results not provided).Siemens is investigating.
Event or Problem Description
A false positive advia centaur cp rubella g (rub g) result was obtained for a patient sample.The patient sample was sent to a reference laboratory (npl) and the rubella g result was non-reactive.In general, the customer performs duplicate testing of samples, and will report a result if they are the same.The non-reactive result from the reference laboratory was reported to the provided.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant rubella g result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2017-00220 on 11/03/2017 for a false positive advia centaur cp rubella g (rub g) patient result.11/07/17 - additional information: a siemens customer service engineer (cse) returned to the customer site.The cse replaced the base sample dilutor, grey peri-pump, and checked precision that was acceptable.While there were multiple parts replaced by the cse while troubleshooting, the root cause is unknown.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR CP 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: 7001357
• Report Number: 1219913-2017-00220
• Device Sequence Number: 1353963
• Product Code: LFX
• UDI-Device Identifier: 00630414201412
• UDI-Public: 00630414201412
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K003412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2017

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: 01/27/2018
• Device Model Number: N/A
• Device Catalogue Number: 10310283
• Device Lot Number: 068196
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 11/03/2017
• Supplement Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1