• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP RUBELLA G (RUB G); RUBELLA G IMMUNOASSAY Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8524859
MDR Text Key145962267
Report Number1219913-2019-00055
Device Sequence Number1
Product Code LFX
UDI-Device Identifier00630414201412
UDI-Public00630414201412
Combination Product (y/n)N
PMA/PMN Number
K003412
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/19/2019
Device Model NumberN/A
Device Catalogue Number10310283
Device Lot Number68942208
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/02/2019
Initial Date FDA Received04/17/2019
Supplement Dates Manufacturer Received04/25/2019
Supplement Dates FDA Received05/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age25 YR
-
-