MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP ANTI-HBS2 (AHBS2); AHBS2 IMMUNOASSAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

The customer states quality control (qc) has had instances where the negative result is higher and out of range.Qc data provided by the customer.Siemens lot# 1921600.(b)(6).The customer replaced the primary pack and repeated qc with success.A siemens field service engineer (fse) was sent to the customer site for system inspection.The fse performed the following: the probe alignments and dispenses were checked.The acid and base dispense was with in tolerance.The acid pump had some dried residue on and below the pump.The pump didn't leak and dispensed correctly.All aspirate probes were aspirating within tolerance.The dark count were in range.All fittings were tight.There were no leaks present.The quality control (qc) was in range for ahbs2.All other qc was in range.The customer had a sample that recovered (b)(6) with advia centaur xp anti-hbs2 lot 102 but recovered (b)(6) when repeated.The customer also had a (b)(6) result that recovered high out of range.When the customer replaced the advia centaur xp anti-hbs2 lot 102 reagent readypack, the (b)(6) recovered in range.The customer does not know how long the sample was allowed to clot or how it was centrifuged because that was done offsite.The cause of the initial elevated result with advia centaur xp anti-hbs2 lot 102 could not be determined but siemens cannot rule out pre-analytical factors, sample issue, or a reagent shipping/handling issue.Based on the investigation, no product problem was identified.The instrument is performing within specifications.No further evaluation of the device is required.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 Description

A (b)(6) advia centaur xp anti-hbs2 (ahbs2) result was obtained for a patient sample.The sample was repeated and the result was (b)(6).The initial positive result was not reported to the physician.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the anti-hbs2 results.

• Brand Name: ADVIA CENTAUR XP ANTI-HBS2 (AHBS2)
• Type of Device: AHBS2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 8485210
• MDR Text Key: 148629795
• Report Number: 1219913-2019-00050
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414561790
• UDI-Public: 00630414561790
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2020
• Device Model Number: N/A
• Device Catalogue Number: 10286268
• Device Lot Number: 83933102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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