MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAY; 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 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

This is a case of one patient sample resulted (b)(6) with advia centaur xp anti-hbs2 reagent lot 119098.However, obtained (b)(6) result with repeat testing using the same sample tube.Patient is (b)(6) with (b)(6) biomarkers.There is no indication of patient receive (b)(6) vaccination.Additionally, there was no evidence of fibrin in the sample.The customer service engineer (cse) was at the customer site investigating another issue.The cse decontaminated the analyzer and determined contamination tests are okay.Post-service, a (b)(6) result was obtained upon repeating the affected patient sample with anti-hbs2 assay.Based on the information available, there may have been non-specific interference between sample and reagent giving (b)(6) result.The advia centaur xp anti-hbs2 ous instruction for use (ifu) (10629819_en rev.K, 2017-12) states under interpretation of results section "nonreactive: samples with an initial value of less than 8 miu/ml are considered nonreactive (negative) for antibodies to hbsag." further repeat testing is not required as per assay ifu.Review of in-house data shows the performance of lot 119098 met all release criteria.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

A (b)(6) result was obtained for a patient sample upon repeat.The initial result was (b)(6) and the second replicate of the repeat testing was (b)(6).The (b)(6) result was reported to the physician.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the (b)(6) results.

• Brand Name: ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAY
• 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: 8199452
• MDR Text Key: 132388778
• Report Number: 1219913-2018-00306
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414561790
• UDI-Public: 00630414561790
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2020
• Device Model Number: N/A
• Device Catalogue Number: 10286268
• Device Lot Number: 65758098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/27/2018
• 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
• Patient Age: 69 YR