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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 11/11/2018

Event Type  malfunction  

Manufacturer Narrative

The cause for the (b)(6) advia centaur xp anti-hbs2 (ahbs2) result(s) is being investigated by siemens.

Event Description

The customer observed a (b)(6) patient result on a new reagent lot (119096) received.The (b)(6) result was considered to be discordant compared to a (b)(6) repeat result, and the patient's clinical history.The customer has reported observing this issue on other patient samples where (b)(6) results were not confirmed to be (b)(6) based the patient's clinical history, other (b)(6) markers, or repeat (b)(6) alternate (b)(6) test method results.Result information for the other patients has not been provided.The customer stated that no discordant (b)(6) results have been reported to physicians, and the results reported have not been questioned.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xp (b)(6) result.

Manufacturer Narrative

Siemens filed mdr on (b)(6) 2018for a non-reproduced false positive advia centaur xp anti-hbs2 (ahbs2) patient result.01/11/2019 additional information: siemens has completed the incident investigation.Based on the information provided, the cause of the non-reproduced false positive advia centaur xp anti-hbs2 (ahbs2) patient result is unknown, and appears to be a site specific issue.A review of complaints was performed, and there were no other similar complaints found regarding imprecision for reagent lots 119094 and 119096.The advia centaur xp anti-hbs2 reagent lots 119094 and 119096 are performing as intended.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAY
• Type of Device: AHBS IMMUNOASSAY,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8146843
• MDR Text Key: 130657227
• Report Number: 1219913-2018-00301
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414561790
• UDI-Public: 00630414561790
• Combination Product (y/n): N
• PMA/PMN Number: P100039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

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: 05/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 10286268
• Device Lot Number: 119096
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1