MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP BR; BR (CA 27.29) IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer provided results for heterophilic ab testing: (b)(6).Siemens healthcare diagnostics is investigating.Mdr 1219913-2019-00046 (for test results on (b)(6) 2019) was filed for the same event.
Event or Problem Description
A falsely high patient sample result of >450 u/ml was obtained on (b)(6) 2019 using advia centaur xp br ((b)(4)) assay with reagent lot 047234 and calibrator lot cg40.The customer repeated testing of the sample with x10 and x20 automatic onboard dilutions and obtained over-dilution errors and repeated with a manual dilution, at 1:5 which resulted at 34.5 u/ml.Repeat testing was performed on (b)(6) 2019 resulting in an additional high neat result and over-dilution error.The sample was later run on the same day on a different advia centaur and resulted at 7.24 u/ml without over-dilution errors.False high results were not reported to the physician.There was no report of adverse health consequences due to the high patient result.
Additional Manufacturer Narrative
The following mdrs were filed on march 28, 2019 reporting falsely high results with the br (ca 27.29) assay on the advia centaur xp; mdr 1219913-2019-00046 (for test results on 2/28/2019) (for test results on 3/4/2019).April 4, 2019 - additional information.Customer service engineer (cse) inspected instruments and no issues were identified.The customer performed a post-service precision study using qc on both instruments and results were acceptable per customer response (no results provided).Siemens investigation is complete.Based on the information provided, siemens is unable to rule out a sample specific issue.No product problem has been identified.The customer is operational.Mdr 1219913-2019-00046 supplemental report 1 (for test results on 2/28/2019) was filed for the same event.

• Brand Name: ADVIA CENTAUR XP BR
• Common Device Name: BR (CA 27.29) IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8462176
• Report Number: 1219913-2019-00049
• Device Sequence Number: 19577670
• Product Code: MOI
• UDI-Device Identifier: 00630414196657
• UDI-Public: 00630414196657
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K982680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2019
• Device Model Number: N/A
• Device Catalogue Number: 10333349
• Device Lot Number: 047234
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1