MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) ASSAY; AHBS2 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	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens field service engineer (fse) was sent to the customer site for system inspection.The fse performed system checks.No issues were identified.The fse noticed the serum separator gel is different on both tubes.The gel from tube collected on (b)(6) has even surface while gel on tube collected on (b)(6) is slanted indicating two different centrifuges were used to spin each sample.The fse performed precision checks on low and high quality control (qc) with 5 reps each.The qc was acceptable.The customer stated that they do not routinely check the sample integrity unless they get a sample probe/sampling error and the sample was not processed on an alternate analyzer.The customer stated that they do not have access to any medical history on the patient.Siemens healthcare diagnostics is investigating.The ifu states in the interpretation of results section: "results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.".
Event or Problem Description
A false reactive advia centaur xpt anti-hbs2 (ahbs2) result was obtained for a patient sample.The result was reported to the physician and was not questioned.A new sample was tested and the result was nonreactive.The new sample was repeated and the result was nonreactive.The original sample was repeated and the result was nonreactive.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the anti-hbs2 results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2018-00268 on november 09, 2018.11/16/2018 additional information: the customer observed inconsistent results (14.45 and 4.23 miu/ml) with pour-off, however consistent results (<3.10 and 4.88 miu/ml) with the bd serum master tube.At this time medical history is not known.Customer service engineer (cse) inspected the analyzer and obtained expected result with anti-hbs2 qc material in n = 5 replicates.Additionally, cse observed gel tube collected on 10/16 has even surface while gel on tube collected on 10/18 is slanted indicating two different centrifuges were used to spin each sample.The advia centaur xp anti-hbs2 us instruction for use (ifu) (10698735_en rev.J, 2016-09) in interpretation of results section states "retest zone: samples with an initial value >/=8 and < 12 miu/ml.If results are within the retest zone after initial testing, samples must be retested in duplicate.After retesting, if 3 results are available and 2 results are >/=10 miu/ml, then the sample is considered to be reactive.If 3 results are available and 2 results are < 10 miu/ml, then the sample is considered to be nonreactive." the issue is likely caused by non-specific interference between sample and reagent as a result causing the difference in results with pour-off.There was no indication of other samples being impacted during this occurrence.Review of in-house data shows the performance of lot 119096 met all release criteria.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) ASSAY
• Common Device Name: AHBS2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8054607
• Report Number: 1219913-2018-00268
• Device Sequence Number: 11144576
• Product Code: LOM
• UDI-Device Identifier: 00630414591407
• UDI-Public: 00630414591407
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100039
• 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): 11/29/2018

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: 05/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 10698706
• Device Lot Number: 53548096
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1