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 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant advia centaur xp anti-hbs2 (ahbs2) results observed by the customer is being investigated.A review of field patient data from december 2, 2018 - january 11, 2019 shows a median value of 9.40 miu/ml with reagent lot 119098, and a median value of 9.54 miu/ml with reagent lot 119102.There is no indication of a shift in the population of results between the two reagent lots.Patient panel samples tested internally do not show the same bias between advia centaur ahbs2 lots 119098 and 119102 observed by the customer.Siemens patient panel result (miu/ml): (b)(6).

Event Description

(b)(6) advia centaur xp anti-hbs2 (ahbs2) results were obtained by the customer when performing a reagent lot (119098) to a new reagent lot (119102) comparison study.The (b)(6) ahbs2 results with reagent lot 119098 were questioned by the physician(s), and a corrected report was issued.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xp anti-hbs2 (ahbs2) results.

Manufacturer Narrative

Siemens filed mdr on 01/19/2019 for false positive advia centaur xp anti-hbs2 (ahbs2) reagent lot correlation results.01/24/2019 - additional information: siemens has completed the incident investigation.A review of internal data and field data from other customers does not show the same bias between advia centaur xp anti-hbs2 reagent lot 119098, and reagent lot 119102 with patient samples.The advia centaur xp anti-hbs2 (ahbs2) reagent kits (3) for lot 119098 used by the customer were part of the same shipment.The root cause of the high recovery the customer saw with advia centaur xp anti-hbs2 (ahb2) reagent lot 119098 is unknown, however a shipping/handling issue with the reagents cannot be ruled out.Based on the available information, the advia centaur xp anti-hbs2 (ahb2) reagent lot 119098 is 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: 8260789
• MDR Text Key: 135156163
• Report Number: 1219913-2019-00004
• 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: 02/15/2019

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: 07/26/2020
• Device Model Number: N/A
• Device Catalogue Number: 10286268
• Device Lot Number: 119098
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1