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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 03/04/2019

Event Type  malfunction  

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 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.

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
• Type of Device: BR (CA 27.29) IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8462176
• MDR Text Key: 145246820
• Report Number: 1219913-2019-00049
• Device Sequence Number: 1
• Product Code: MOI
• UDI-Device Identifier: 00630414196657
• UDI-Public: 00630414196657
• Combination Product (y/n): N
• PMA/PMN Number: K982680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1