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 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

The customer's blood collection tube handling is in line with sarstedt recommendations assuming the radius of their centrifuge is at least 200 millimeters.The clinical sensitivity and specificity section of the advia centaur xp anti-hbs2 instructions for use (ifu) (10629819 revision k) lists the 95% confidence interval (ci) for resolved relative specificity as 98.34% - 99.88%.Given the customer has only had an issue with one sample there is no indication that the advia centaur xp ahbs2 lot 102 is failing to meet the specificity claim in the ifu.A review of internal data for advia centaur xp anti-hbs2 lot 102 indicates it is performing as intended.The cause of the positive result with the advia centaur xp anti-hbs2 lot 102 could not be determined.Siemens cannot rule out normal assay performance, pre-analytical factors, or a sample issue.Based on the investigation, no product problem was identified.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

A (b)(6) advia centaur xp anti-hbs2 (ahbs2) result was obtained for a patient sample.The (b)(6) result was questioned by the physician.The sample was repeated and the same advia centaur xp system and the result was (b)(6).A second sample was tested, and the result was (b)(6).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: 8456934
• MDR Text Key: 145529570
• Report Number: 1219913-2019-00043
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414561790
• UDI-Public: 00630414561790
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/27/2019

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: 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
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2018
• 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: 87 YR