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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

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

Event Date 09/01/2018

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant advia centaur xpt rubella g (rub g) results obtained on a patient sample from two different reagent lots is unknown.Siemens is investigating.Mdr 1219913-2018-00246 was filed for an initial false positive result from the same patient.

Event Description

False positive advia centaur xpt rubella g (rub g) results were obtained on a patient sample from two different reagent lots.The positive results were considered discordant compared to negative rubella g alternate test method result(s) during the patient's pregnancy.There are no reports that treatment was altered or prescribed or adverse health consequences due to the positive advia centaur xpt rubella igg results.Mdr 1219913-2018-00246 was filed for an initial false positive result from the same patient.

Manufacturer Narrative

Siemens filed mdr 1219913-2018-00247 on 10/08/2018 for a false positive advia centaur xpt rubella g (rub g) result obtained on a patient sample.Mdr 1219913-2018-00247 supplemental report 1 was filed on 12/06/2018, and mdr 1219913-2018-00247 supplemental report 2 was filed on 12/13/2018 for additional information.12/21/2018 - additional information: siemens has completed the incident investigation.A reviewed of the adjustments and quality control (qc) data provided were within acceptable ranges, and comparable with siemens quality control kit release data.The customer tested the 2nd sample with heterophilic blocking tubes (hbt), and the rubella g result remained positive with almost identical value as the non-hbt sample.The customer did not question any other patient results for any of the assays performed on the system; therefore a customer service engineer was not onsite.The patient sample was not provided to siemens for further testing.The cause of the positive rub g results cannot be determined, and appears to be isolated to this patient sample.Siemens was unable to obtain further information from the customer regarding relative specificity; however 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, the advia centaur xpt rubella igg reagent lots 068202 and 068204 are performing as intended.No further evaluation of the device is required.Mdr 1219913-2018-00246 was filed for an initial false positive result from the same patient.Mdr 1219913-2018-00246 supplemental report 1, mdr 1219913-2018-00246 supplemental report 2, and mdr 1219913-2018-00246 supplemental report 3 were filed for additional information.

Manufacturer Narrative

Siemens filed mdr 1219913-2018-00247 on 10/08/2018 for a false positive advia centaur xpt rubella g (rub g) result obtained on a patient sample.11/14/2018 - additional information: the customer has provided the results for non-specific antibody blocking tube (nabt) testing.Siemens is investigating the incident.Rub g result = 83.1 iu / ml nabt rub g result = 77.9 iu / ml quality control (qc) of the day was ok.Analyzes done on the (b)(6) 2018.Mdr 1219913-2018-00246 was filed for an initial false positive result from the same patient, and mdr 1219913-2018-00246 - supplemental report 1 for additional information.

Manufacturer Narrative

Siemens filed mdr 1219913-2018-00247 on (b)(6) 2018 for a false positive advia centaur xpt rubella g (rub g) result obtained on a patient sample, and mdr 1219913-2018-00247 supplemental report 1 on 12/06/2018 for additional information.11/14/2018 - additional information: the rub g result (83.1 iu/ml) was for heterophilic blocking tube (hbt).Siemens is investigating the incident.Rub g result (hbt) = 83.1 iu / ml.Mdr 1219913-2018-00246 was filed for an initial false positive result from the same patient.Mdr 1219913-2018-00246 supplemental report 1, and mdr 1219913-2018-00246 supplemental report 2 were filed for additional information.

• Brand Name: ADVIA CENTAUR XPT RUBELLA G (RUB G) ASSAY
• Type of Device: RUBELLA G IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7945061
• MDR Text Key: 125134833
• Report Number: 1219913-2018-00247
• 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,Followup,Followup
• Report Date: 01/11/2019

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 Date: 12/14/2018
• Device Model Number: N/A
• Device Catalogue Number: 10310283
• Device Lot Number: 068202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/08/2018
• Supplement Dates Manufacturer Received: 11/14/2018; 11/14/2018; 12/21/2018
• Supplement Dates FDA Received: 12/06/2018; 12/13/2018; 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR