MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOTICS, INC ADVIA CENTAUR XPT HBSAGII ASSAY; HBSII IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant (b)(6) results is unknown.Siemens has received samples for testing.The advia centaur/xp/xpt hbsagii information for use (ifu) states in the limitations section: "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis.For diagnostic purposes, the advia centaur hbsagii test results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings." the advia centaur/xp/xpt hbsagii information for use (ifu) states in the interpretation of results section: "samples with an index value of >/= 1.0 but
Event or Problem Description
The customer observed initial (b)(6) results that were (b)(6).(b)(6) results were not confirmed.Additional testing of the same sample and a subsequent sample from the same patient yielded (b)(6) results and not confirmed conf results.A previous (b)(6) result was (b)(6).The customer stated that a result of (b)(6) was reported to the physician.The patient is a dialysis patient.Based on the (b)(6) results, the patient was placed on a dialysis machine that is used for patient with (b)(6) results.There are no reports of adverse health consequences due to the (b)(6) results.The patient is now deceased due possible kidney failure.Mdr 1219913-2018-00174 is being filed for sample test results generated on may 15, 2018 for the same patient.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2018-00162 on june 14, 2018 reporting the observation of initial advia centaur xpt hbsagii results that were (b)(6) but did not confirm with the advia centaur xpt hbsagii confirmatory test.Mdr 1219913-2018-00174 was filed for sample test results generated on (b)(6) 2018 for the same patient.June 29, 2018 - additional information (b)(6).The advia centaur/xp/xpt hbsagii information for use (ifu) states in the limitations section: "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis.For diagnostic purposes, the advia centaur hbsagii test results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings." the results from the plasma samples did not confirm the results from the serum tube.No further investigation is required.Mdr 1219913-2018-00174 was filed for sample test results generated on (b)(6) 2018 for the same patient.Mdr 1219913-2018-00174 supplemental report 1 is filed with the results of siemens' testing as well.

• Brand Name: ADVIA CENTAUR XPT HBSAGII ASSAY
• Common Device Name: HBSII IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOTICS, INC; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7601615
• Report Number: 1219913-2018-00162
• Device Sequence Number: 19307241
• Product Code: LOM
• UDI-Device Identifier: 00630414578170
• UDI-Public: 00630414578170
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P030049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2018

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: 02/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 10492138
• Device Lot Number: 88321140
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1