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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant rubella g results is unknown.Siemens healthcare diagnostics is investigating.The ifu states in the warning section: "the use of the advia centaur rubella g assay to diagnose recent infection by testing acute and convalescent samples is not recommended.The calculated values for rubella igg in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the rubella igg assay used.Values obtained with different assay methods cannot be used interchangeably.The reported igg level cannot be correlated to an endpoint titer." mdr 1219913-2019-00053 (patient 1) and 1219913-2019-00054 (patient 2) were filed for the same event.

Event Description

A false positive advia centaur xp rubella g (rub g) result was obtained for a patient sample.The patient sample was tested on an alternate method and the result was negative.The physician questioned the positive result.A corrected report was issued.The patient is pregnant.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant rubella g result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00055 on april 17, 2019.04/25/2019 correction: the patient information is incorrectly documented as patient 2, sample (b)(6).The correct patient information is patient 3, sample (b)(6).05/15/2019 additional information: siemens has made multiple requests for additional information required to evaluate this escalation but has not received the requested information from the customer.The customer reported false positive results of 3 patients for rubella g (rub g) when tested on the advia centaur xp using reagent lot 208 and negative with an alternate method.Siemens technical solution center provided hbt/nabt tubes for additional testing but the customer did not provide any additional testing information or results.Information on sample handling and the calibration were requested and not provided.Siemens reviewed the customer's quality control (qc) data and noted that customer's qc was out prior and during the reporting of the patients' results.Customer has not been able to provide information needed to calculate the relative specificity on this account with rubella g (rub g) lot 208.The initial relative specificity of 3 studies in the advia centaur xpt rubella igg (10629891_en rev.T, 2016-04) instructions for use (ifu) has a range of 95.4-100%.Based on the available information centaur xp rubella igg lot 208 is performing as intended.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00053 supplemental report 1 (patient 1) and mdr 1219913-2019-00054 supplemental report 1 (patient 2) were filed for the same event.

• Brand Name: ADVIA CENTAUR XP RUBELLA G (RUB G)
• Type of Device: RUBELLA G IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8524859
• MDR Text Key: 145962267
• Report Number: 1219913-2019-00055
• Device Sequence Number: 1
• Product Code: LFX
• UDI-Device Identifier: 00630414201412
• UDI-Public: 00630414201412
• Combination Product (y/n): N
• PMA/PMN Number: K003412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2019
• Device Model Number: N/A
• Device Catalogue Number: 10310283
• Device Lot Number: 68942208
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR