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 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has requested the patient sample for further testing and investigation.Mdr 1219913-2019-00038 (sid (b)(6)) and mdr 1219913-2019-00039 (sid (b)(6)) were filed for the same event.

Event Description

Discordant advia centaur xp anti-hbs2 (ahbs2) results were obtained for three samples from the same patient.The patient was tested on the advia centaur xp in (b)(6) 2018 (sid (b)(6)), (b)(6) 2018 (sid (b)(6)), and (b)(6) 2019 (sid (b)(6)).The samples from (b)(6) 2018 were tested on an alternate method and the results were (b)(6).A different sample from the same patient (sid (b)(6)) was tested on the alternate method in (b)(6) 2019 and the result was (b)(6).The sample from (b)(6) 2019 was not tested on the advia centaur xp.The results were questioned by the physician.Corrected reports were issued.Pregnant patient with chronic (b)(6).Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the anti-hbs2 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00040 on march 20, 2019.04/16/2019 additional information: the customer had samples ((b)(6) 2018 - (b)(6) 2019) from a pregnant chronic hepatitis b patient are recovering from 92 - 122 miu/ml with the advia centaur xp ahbs2 assay (lots 094, 096, and 102) but nonreactive with the alternate anti-hbs methods.Advia centaur xp hbsii assay (>1000 index) and advia centaur xp hbct assay (4.77 index) results are in alignment with chronic hepatitis b infection.Siemens tested the sample with the advia centaur xp ahbs2 lot 098 and it recovered reactive (98 miu/ml), so the issue with the sample is not specific to the lots used by the customer or to the customer's instrument.The sample was also tested with the immulite 2000 anti-hbs assay and recovered nonreactive (<3.00 miu/ml) which confirms the nonreactive result of the alternate anti-hbs methods.Siemens tested the sample with the dimension vista rheumatoid factor (rf) assay but levels were well within the normal range.The sample was also diluted with multi diluent 11 and tested the dilutions with the advia centaur xp ahbs2 assay.The sample remained reactive even upon dilution.Additional testing was not able to identify an interferent in the patient's sample that is elevating the advia centaur xp ahbs2 result.Ahbs2 results (miu/ml): advia centaur xp: 98.68 and 98.17, immulite 2000: <3.00 and <3.00, dimension vista rheumatoid factor (rf) result iu/ml): <10.0 and <10.0.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 samples from this one patient there is no indication advia centaur xp ahbs2 lot 102 is failing to meet the specificity claim in the ifu.The cause of the elevated results with samples from this one patient when using the advia centaur xp ahbs2 assay could not be determined but siemens cannot rule out 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.Mdr 1219913-2019-00038 supplemental report 1 ((b)(6)) and mdr 1219913-2019-00039 supplemental report 1 ((b)(6)) were filed for the same event.

• 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
• MDR Report Key: 8435738
• MDR Text Key: 142792936
• Report Number: 1219913-2019-00040
• 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: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• 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: 102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR