MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR HBSAGII ASSAY; HBS 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 04/23/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was sent to the customer site for system inspection.The cse performed a total service call that was acceptable.The acid pump, sample probe and guide for serum splatter were replaced, and the r3 probe calibration optimized.The cse ran ten sample replicates from five different patients successfully.The cause for the (b)(6) results is unknown.At the time of the event, the customer's quality control results for (b)(6) were within range.No conclusion can be drawn.The instruction for use (ifu) under the limitation section states the following: "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 instruction for use (ifu) under the interpretation of results section states the following: "if the sample is greater than 50 or flagged as "> index range," the specimen is reactive (positive) for hbsag, and no further testing is required.Note when the advia centaur hbsagii assay is used as a stand-alone assay (for example in pregnant women being screened to identify neonates who are at risk for acquiring hbv during the perinatal period), it is suggested that the advia centaur hbsag confirmatory assay be used to confirm the result." the instrument is performing within specifications.No further investigation is required.

Event Description

(b)(6) advia centaur hbsagii results were obtained by the customer on a patient sample and considered (b)(6) compared to (b)(6) results and (b)(6) confirmatory testing.A (b)(6) result was reported by the customer.There was no known report of patient treatment being altered or adverse health consequences due to the (b)(6) advia centaur hbsagii assay results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2016-00080 on 05/19/2016 for (b)(6) patient results.On 06/24/2016 correction: there was an advia centaur (b)(4) reagent lot number typographical error.The reagent lot number 119066 that was initially reported was incorrect.The correct reagent lot number was 109066.The udi number previously recorded was correct.No further investigation is required.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2016-00080 on 05/19/2016 for (b)(6) advia centaur hbsag ii patient results, and mdr 1219913-2016-00080 supplemental report 1 on 06/24/2016 for a reagent lot number typographical correction.Update 07/02/2016: additional information: the customer sent the patient sample to another laboratory with an advia centaur system, and the (b)(6) result was (b)(6).The cause for the initially (b)(6) advia centaur hbsagii results is unknown.No conclusion can be drawn.The instrument is performing within specifications.No further investigation is required.

• Brand Name: ADVIA CENTAUR HBSAGII ASSAY
• Type of Device: HBS IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• 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: 5668275
• MDR Text Key: 45578519
• Report Number: 1219913-2016-00080
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2016
• Device Model Number: N/A
• Device Catalogue Number: 10492138
• Device Lot Number: 119076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2015
• 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