MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR 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 04/25/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating.Mdr 1219913-2019-00078 (for test results on (b)(6) 2018) was filed for the same event.Mdr 1219913-2019-00079 (for test results on (b)(6) 2019) was filed for the same event.Mdr 1219913-2019-00091 (for test results on (b)(6) 2019) was filed for the same event.Mdr 1219913-2019-00092 (for test results on (b)(6) 2019) was filed for the same event.

Event Description

A customer obtained (b)(6) results with the advia centaur xpt anti-hbs2 (ahbs2) assay for 6 patient samples.The 6 patient samples were tested with the advia centaur xpt hbsagii (hbsii) assay and (b)(6) results were obtained.The 6 patient samples were also tested with an alternate method and the ahbs results were (b)(6) but the hbsag were (b)(6).The customer considers the advia centaur xpt anti-hbs2 (ahbs2) results to be discordant ((b)(6)).Initial results were not reported to the physician.There was no report of adverse health consequences due to the advia centaur xpt anti-hbs2 (b)(6) results.

Manufacturer Narrative

Siemens filed initial mdr on may 17, 2019.Additional information from 08/19/2019: the customer observed (1) patient sample that recovered repeatedly reactive with advia centaur xpt anti-hbs2 lot: 092 and (6) patient samples that recovered repeatedly reactive with advia centaur xpt anti-hbs2 lot: 102.All 6 samples were reactive when tested with advia centaur xpt hbsii lot: 160.When tested with an alternate ahbs method all samples were non-reactive but positive with an alternate hbsag method.There was no remaining volume of any patient sample, therefore no further investigation is possible.In addition, the customer was not able to provide information regarding medications, supplements or medical history of any of the patients.The clinical sensitivity and specificity section of the advia centaur xp/xpt anti-hbs2 instructions for use (ifu) (10629819, revision k, 2017-12) lists the 95% confidence interval (ci) for resolved relative specificity as 98.34% - 99.88% so a certain number of false positive results can be expected for this assay.Based on this, advia centaur xp ahbs2 lot: 102 is meeting the specificity claim in the ifu since (5) false positive samples out of the 581 nonreactive samples tested by the customer would mean a specificity of 99.1%.And given the customer has only had an issue with (1) sample when using advia centaur xpt ahbs2 lot: 092 there is no indication lot: 092 is failing to meet the specificity claim in the ifu.The cause of the elevated results with samples when using advia centaur xpt anti-hbs2 lots: 092 and 102 could not be determined but siemens cannot rule out normal assay performance, pre-analytical factors, or sample issues.Based on the investigation, no product problem was identified.No further evaluation of the device is required.Mdr 1219913-2019-00078 supplemental report 1 (for test results on (b)(6) 2019) was filed for the same event.Mdr 1219913-2019-00079 supplemental report 1 (for test results on (b)(6) 2019) was filed for the same event.Mdr 1219913-2019-00091 supplemental report 1 (for test results on (b)(6) 2019) was filed for the same event.Mdr 1219913-2019-00092 supplemental report 1 (for test results on (b)(6) 2019) was filed for the same event.

• Brand Name: ADVIA CENTAUR 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: 8621392
• MDR Text Key: 205576325
• Report Number: 1219913-2019-00093
• 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: 09/24/2019

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: 119102
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: 08/19/2019
• Supplement Dates FDA Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1