MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT 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 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) has checked the advia centaur r3 probe alignments, dispensing, sample probe, the dry, wet water, and wet wash rlus and repeatability of the low calibrator.The cause for the discordant advia centaur xpt rubella g result compared to the advia centaur xp, and alternate test method is unknown.Siemens is investigating.

Event Description

A false positive advia centaur xpt rubella g (rubg) result was observed by the customer, and considered discordant compared to a negative advia centaur xp rubella g, and alternate rubella igg test method.The discordant advia centaur xpt result was not reported to the physician.There are no reports that treatment was altered or prescribed or adverse health consequences due to the positive result on the advia centaur xpt rubg assay.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2017-0009 on 01/30/2017 for a false positive advia centaur xpt rubella g (rub g) patient result.07/06/17 - 07/07/17 - additional information: the customer service engineer (cse) had found bacteria contamination in the water system that supplies the fluidics in the system, and decontamination was performed.The quality control (qc) results were checked, and acceptable.A precision check with the positive qc control (mean value 20 iu/ml) was acceptable.A check of rub g results between the advia centaur xpt and alternate advia centaur xp system around the cutoff was concordant.07/13/2017 - investigation conclusion: the initial issue was reported as a discordant advia centaur xpt rubella igg result.The siemens customer service engineer (cse) performed a check of the system, and found bacteria contamination in the water.The system was decontaminated, and performed calibration with valid results.The cse performed quality control (qc) with all results in range, and concordant results compared to the advia centaur xp, and alternate rubella g test method.The cause for the discordant advia centaur xpt rubella g (rubg) result is unknown, as the discordant advia centaur xpt result was not reproduced prior to system decontamination.No conclusion can be drawn.The instrument is performing within specification.No further investigation is required.

• 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole, MA 02032
• Manufacturer Contact: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 6287665
• MDR Text Key: 66144684
• Report Number: 1219913-2017-00009
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K003412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 07/13/2017

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: No Information
• Device Expiration Date: 06/24/2017
• Device Model Number: N/A
• Device Catalogue Number: 10310283
• Device Lot Number: 75757193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 01/30/2017
• Supplement Dates Manufacturer Received: 07/06/2017
• Supplement Dates FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• 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
• Patient Age: 28 YR