MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF); TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant results is unknown.Siemens healthcare diagnostics is investigating.The instructions for use (ifu) states in the interpretation of results section: "it has been reported that certain assays will not detect all hbv mutants.If acute or chronic hbv infection is suspected and the advia centaur hbsii result is nonreactive, it is recommended that other hbv serological markers be tested to confirm the advia centaur hbsii nonreactivity." the instructions for use (ifu) states in the limitations section: "the performance of the assay has not been established for populations of immunocompromised or immunosuppressed patients.Do not use specimens with obvious microbial contamination.Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.7 patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis.Samples containing heterophilic antibodies should not be neutralized using the advia centaur conf assay." mdr 1219913-2020-00030 was filed for the same event for the january 13, 2020 test result.

Event Description

A customer obtained an erroneous result with the advia centaur xp hbsag confirmatory (conf) assay.A patient was diagnosed in (b)(6) 2019 as (b)(6) for (b)(6) infection (results/method unknown).On (b)(6) 2019, a sample from the patient was tested with the advia centaur xp hbsag confirmatory (conf) assay after having obtained a high positive result for advia centaur xp hbsagii; a result of not confirmed was obtained.Result was reported to physician, who did not question the result.A second sample was drawn from the same patient on (b)(6) 2020 and was tested with the advia centaur xp hbsag confirmatory (conf) assay after having obtained a high positive result for advia centaur xp hbsagii; a result of not confirmed was obtained again.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the not confirmed advia centaur xp (b)(6) confirmatory results.

Manufacturer Narrative

Siemens filed initial mdr 1219913-2020-00029 on (b)(6) 2020.Additional information (b)(6) 2020: the customer indicated that no sample is available and additional information would not be sent because the customer believes the issue to be resolved.The customer believes that dilution data indcates a sample specific issue and not an instrument related issue.Additional information (b)(6) 2020: a customer tested a sample in (b)(6) 2019 that was reactive (987 index) with advia centaur xp hbsagii (hbsii) reagent lot 192 but was "not confirmed" with the advia centaur xp hbsag confirmatory (conf) assay.The sample was hbv dna positive (196,549,663 iu/ml), ahbs2 nonreactive (< 3.1 miu/ml), hbct reactive (2.62 index), hbcm nonreactive (0.16 index), hbeag positive (> 1000 index), and ahbe nonreactive (0 index).A new draw from the same patient in (b)(6) 2020 was also reactive (786 index) with advia centaur xp hbsii reagent lot 196 but was "not confirmed" with the advia centaur xp conf assay.The new draw was hbv dna positive (358,563 iu/ml), ahbs2 nonreactive (< 3.1 miu/ml), hbct reactive (2.98 index), hbcm nonreactive (0.16 index), hbeag positive (> 1000 index), and ahbe nonreactive (0 index).The patient is a 16-year-old male with non-western european origin, with a positive hepatitis b infection diagnosed in november 2019.The customer was not able to provide a list of medications/supplements the patient is taking.The customer was not able to provide the lot of advia centaur xp conf used and/or the relative light units (rlus) associated with the original data.There is no sample that can be sent to siemens for evaluation.A high titer hepatitis b virus (hbv) positive sample should give a result of "redilute", not "not confirmed".The "not confirmed" results obtained by the customer with this sample appear to only occur with 1:2500 autodilutions, not with 1:50 autodilutions, so it is possible the instrument is having trouble making dilutions of dilutions (the 1:2500 autodilution is a 1:50 autodilution of a 1:50 autodilution).The method comparison section of the advia centaur xp/xpt conf instructions for use (ifu) (11199841 revision u, 2019-08) lists the 95% confidence interval (ci) for hepatitis b virus (hbv) positive samples that were confirmed as 98.3% - 100%, so a certain number of false "not confirmed" results can be expected for this assay.The cause of the false "not confirmed" results seen by the customer when using an unknown lot of advia centaur xp conf could not be determined but siemens cannot rule out pre-analytical factors, a sample issue, normal assay performance, or an issue that could have been resolved with routine instrument troubleshooting.Based on the investigation, no product problem was identified.No further evaluation of the device is required.Mdr 1219913-2020-00030 supplemental 1 report was filed for the same event.

• Brand Name: ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF)
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9675951
• MDR Text Key: 203689564
• Report Number: 1219913-2020-00029
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414472874
• UDI-Public: 00630414472874
• Combination Product (y/n): N
• PMA/PMN Number: P030049
• 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: 03/11/2020

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 Model Number: N/A
• Device Catalogue Number: 10309058
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 YR