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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/24/2017

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 interpretation of results section: 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.Sample results are invalid and must be repeated if the controls are out of range.The 10.0 iu/ml or greater results are considered positive in accordance with the clsi guidelines and based on the who international standard for anti-rubella serum as an indicator of immune status and a breakpoint to detect most seropositive persons.The cutoff for the advia centaur rubella igg assay was verified based on results of receiver-operator characteristics (roc) curve and positive/negative predictive values generated from the results of the clinical studies.".

Event Description

A false positive advia centaur xp rubella g (rub g) result was obtained for a patient sample.The patient sample was repeated on another advia centaur xp when the quality control was run and was out of range at a later time.The result for the patient sample was equivocal.A corrected report was issued.The reagent readypack was replaced and the assay recalibrated on the initial advia centaur xp as a recommendation from siemens.The quality control was run and was in range.The patient sample was repeated after the quality control was in range and the result was equivocal.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 1219913-2017-00157 on july 21, 2017.08/02/2017 correction: the unit of measure for the results reported provided by the customer initially were incorrect.The correct unit of measure for the rubella g assay used to report results by the customer is iu/ml.08/04/2017 additional information: the cause for the discordant rubella g result can not be determined.The customer did not notice any visual issues with the reagent pack.The reagent pack was replaced.This appears to be an isolated issue.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 6731744
• MDR Text Key: 80660810
• Report Number: 1219913-2017-00157
• Device Sequence Number: 1
• Product Code: LFX
• UDI-Device Identifier: 00630414201412
• UDI-Public: 00630414201412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2017

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
• Device Operator: Other Health Care Professional
• Device Expiration Date: 11/01/2017
• Device Model Number: N/A
• Device Catalogue Number: 10310283
• Device Lot Number: 21258195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 08/02/2017
• Supplement Dates FDA Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1