MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR® XPT HBSAGII (HBSII); HBSII IMMUNOASSAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

The customer diluted the patient sample with water in 1:5 and 1:10.The 1:5 and 1:10 diluted sample results were (b)(6).The patient sample tested without dilution had a (b)(6) result.The cause for the discordant advia centaur® xpt hbsii results is unknown.Siemens healthcare diagnostics is investigating.The ifu states in the limitations section: "assay performance characteristics have not been established when the advia centaur hbsagii assay is used in conjunction with other manufacturers' assay for specific hbv serological markers.For diagnostic purposes, the advia centaur hbsagii test results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings.It is recognized that the current methods for the detection of hepatitis b surface antigen may not detect all potentially infected individuals.A nonreactive test result does not exclude the possibility of exposure to or infection with hepatitis b.A nonreactive test result in individuals with prior exposure to hepatitis b may be due to antigen levels below the detection limit of this assay or lack of antigen reactivity to the antibodies in this assay." mdr 1219913-2019-00020 (lot 144 testing) and 1219913-2019-00021 (lot 142 repeat testing) were filed for the same event.

Event Description

A discordant (b)(6) advia centaur xpt hbsagii (hbsii) result was obtained for a patient sample with lot 142.The result was reported to the physician and questioned.The patient presents clinical signs of (b)(6).The patient sample was tested at another site and the result was (b)(6).The first sample from the patient was repeated on alternate method 1 and the result was (b)(6).The second sample was repeated on alternate method 2 and the result was (b)(6).The patient sample was tested with the advia centaur xpt hbsagii (hbsii) lot 144 and the result was (b)(6).The patient sample was repeated with the advia centaur xpt hbsagii (hbsii) lot 142 and the result was (b)(6).Patient treatment and intervention were delayed.The customer stated hospitalization of the patient and retroviral medication supply.Currently the patient is hospitalized for treatment of (b)(6).There was no report of adverse health consequences due to the discordant hbsagii result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00017 on february 12, 2019.Siemens filed the mdr 1219913-2019-00017 supplemental report 1 on april 5, 2019.04/15/2019 additional information: the patient is currently at the end of the acute phase of the disease.Given that the patient is at the end of the acute phase of the disease obtaining more sample would not allow siemens to determine why the sample was nonreactive at the beginning of the disease.The advia centaur xpt hbsii instructions for use (ifu) (10635152 revision g, 2017-12) state in the limitations section: "it is recognized that the current methods for the detection of hepatitis b surface antigen may not detect all potentially infected individuals.A nonreactive test result does not exclude the possibility of exposure to or infection with hepatitis b.A nonreactive test result in individuals with prior exposure to hepatitis b may be due to antigen levels below the detection limit of this assay or lack of antigen reactivity to the antibodies in this assay." siemens healthcare diagnostics is awaiting further information.Mdr 1219913-2019-00020 supplemental report 2 and 1219913-2019-00021 supplemental report 2 were filed for the same event.

Manufacturer Narrative

Siemens filed the initial mdr on (b)(6) 2019.03/12/2019 additional information: the customer had a sample that recovered nonreactive (0.10 index) with advia centaur xpt hbsagii lots 142 and 144 but reactive with two alternate hbs methods.When the sample was diluted with water the dilutions recovered reactive with the advia centaur xpt hbsagii assay.Siemens does not recommend diluting samples in water as this will alter the sample (e.G.Protein concentration, viscosity, etc.) in such a way that the result with the diluted sample is not reliable.The sample was sent to siemens for evaluation but there was only ~200ul which was not enough to perform molecular testing and limited the testing that could be done.Siemens tested the sample with advia centaur xpt hbsagii lot 168 and the result was nonreactive.Therefore, the issue with the sample is not lot specific or specific to the customer's reagents.Siemens also diluted the sample with the low calibrator but the sample continued to recover nonreactive.If there is something in the sample interfering with the hbsagii assay, siemens was not able to dilute it out.The dilution results, which went up to 1 20000, do not indicate the nonreactive result was due to a high dose hook effect.According to smart remote services (srs) data at least 1400 positives samples have been tested with advia centaur xpt hbsagii lot 142 and at least 1300 positives samples have been tested with advia centaur xpt hbsagii lot 144.The sensitivity section of the advia centaur hbsii instructions for use (ifu) (10635152 revision g) lists the 95% confidence interval (ci) for sensitivity as 99.09% - 100.00%.Based on this information, the advia centaur xp hbsagii lot 142 and 144 are performing as intended since one false negative result out of 1400 positive results would mean a sensitivity of 99.9% for lot 142 and 1 false negative result out of 1300 positive results would mean a sensitivity of 99.9% for lot 144.While there is insufficient information to determine the cause of the false negative result, siemens cannot rule out typical assay performance, pre-analytical factors, or sample issue.Based on the investigation, no product problem was identified.03/26/2019 additional information received for the patient: january 3: the patient arrives at the emergency room, with myalgia, joint pain and inflammation, so they refer him to the orthopedist.January 18: a joint puncture is performed, with analysis of the liquid.For that moment he presents adynamia and asthenia.Given the symptoms, they send it to the hepatologist, who decides to do the laboratory exams: 1.Pasteur: negative, 2.Other laboratory: positive, 3.Control: negative for hep b.After the confirmation of the results, the patient is hospitalized and the management and treatment is carried out.Siemens healthcare diagnostics is awaiting further information.Mdr 1219913-2019-00020 supplemental report 1 and 1219913-2019-00021supplemental report 1 were filed for the same event.

Manufacturer Narrative

Siemens filed the initial mdr (b)(4) on (b)(6)2019.Siemens filed the mdr (b)(4) supplemental report 1 on (b)(6)2019.Siemens filed the mdr (b)(4) supplemental report 2 on (b)(6)2019.06/21/2019 additional information: the customer had a sample that recovered nonreactive (0.10 index) with advia centaur xpt hbsagii lots 142 and 144 but reactive with the alternate hbs methods.When the sample was diluted with water, the dilutions recovered reactive with the advia centaur xpt hbsagii assay.Siemens does not recommend diluting samples in water as this will alter the sample (e.G.Protein concentration, viscosity, etc.) in such a way that the result with the diluted sample is not reliable.The sample was sent to siemens for evaluation but there was only ~200ul which was not enough to perform molecular testing and limited the testing that could be done.Siemens tested the sample with advia centaur xpt hbsagii lot 168 and the result was nonreactive.So, the issue with the sample is not lot specific or specific to the customer's reagents.The sample was also diluted with low calibrator but the sample continued to recover nonreactive.So, if there is something in the sample interfering with the assay, we were not able to dilute it out.The dilution results, which went up to 1 / 20000, do not indicate the nonreactive result was due to a high dose hook effect.According to smart remote services (srs) data at least 1400 positives samples have been tested with advia centaur xpt hbsagii lot 142 and at least 1300 positive samples have been tested with advia centaur xpt hbsagii lot 144.The sensitivity section of the advia centaur hbsii instructions for use (ifu) (10635152 revision g) lists the 95% confidence interval (ci) for sensitivity as 99.09% - 100.00%.Based on this information advia centaur xp hbsagii lot 142 and 144 are performing as intended since 1 false negative result out of 1400 positive results would mean a sensitivity of 99.9% for lot 142 and 1 false negative result out of 1300 positive results would mean a sensitivity of 99.9% for lot 144.Please note that as stated in the limitations section of the advia centaur xpt hbsii instructions for use (ifu) (10635152 revision g, 2017-12): "it is recognized that the current methods for the detection of hepatitis b surface antigen may not detect all potentially infected individuals.A nonreactive test result does not exclude the possibility of exposure to or infection with hepatitis b.A nonreactive test result in individuals with prior exposure to hepatitis b may be due to antigen levels below the detection limit of this assay or lack of antigen reactivity to the antibodies in this assay." while there is insufficient information to determine the cause of the false negative result, typical assay performance, pre-analytical factors, or sample issue cannot be ruled out.Based on the investigation, no product problem was identified.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00020 supplemental report 3 and 1219913-2019-00021 supplemental report 3 were filed for the same event.

• Brand Name: ADVIA CENTAUR® XPT HBSAGII (HBSII)
• Type of Device: HBSII IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8331944
• MDR Text Key: 139074580
• Report Number: 1219913-2019-00017
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414578170
• UDI-Public: 00630414578170
• Combination Product (y/n): N
• PMA/PMN Number: P110041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/03/2019

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: 02/23/2019
• Device Model Number: N/A
• Device Catalogue Number: 10492138
• Device Lot Number: 97628142
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: 03/12/2019; 04/15/2019; 06/21/2019
• Supplement Dates FDA Received: 04/05/2019; 05/08/2019; 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR