MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAY; 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 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

No instrument errors were found with the system during events.All siemens (b)(6) controls following (b)(6) reagent lots 122 and 120 were all within normal ranges.The type of blood collection tube that was used was plastic gel barrier tubes with clot activators.It is unknown if the patient is vaccinated for (b)(6).The human serum samples cannot be returned due to china customs issues.The cause for the (b)(6) results is unknown.Siemens healthcare diagnostics is investigating.

Event Description

A (b)(6) result was obtained for a patient sample on lot 122.The repeat results run with lot 122 were (b)(6).This sample was repeated with (b)(6) lot 120 on another advia centaur xp system, and the results were (b)(6).The results were not reported to the physician.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant (b)(6) results.

Manufacturer Narrative

Siemens filed the initial mdr on june 3, 2020 reporting that the customer observed reproducible elevated results on a patient's sample with the advia centaur xp anti-hbs2 assay.June 4, 2020 - additional information the customer had a sample that recovered reactive (238.4, 247.3, 257.3 miu/ml) with advia centaur xp anti-hbs2 (ahbs2) lot 122 but when it was tested on another advia centaur xp with ahbs2 lot 120 it recovered nonreactive (<3.1, 4.24, 4.32 miu/ml).Other samples tested that day with lot 122 were retested with lot 120 but no other samples had the same issue.All siemens ahbs2 controls following ahbs2 reagent lots 122 and 120 were within normal ranges.The sample was also hbsii reactive (>1000 index), hbct reactive (>8 index), hbeag reactive (>1000 index), and anti-hbe nonreactive (0 index).The sample was from an anorectal surgery patient.The customer was not able to provide a list of medications/supplements the patient was taking.The sample cannot be sent to siemens for evaluation.The clinical sensitivity and specificity section of the advia centaur xp/xpt anti-hbs2 instructions for use (ifu) (10629819, revision l, 2019-08) lists the 95% confidence interval (ci) for resolved relative sensitivity as 98.30% - 100% and the 95% ci for resolved relative specificity as 98.34% - 99.88% so a certain number of false negative and false positive results can be expected for this assay.This one discrepant sample does not indicate a product problem with advia centaur xp ahbs2 lots 120 and 122.A review of internal data indicates advia centaur xp ahbs2 lots 120 and 122 are performing as intended.The cause of the discrepant results seen by the customer with this one patient sample when using advia centaur xp ahbs2 lots 120 and 122 could not be determined, but siemens cannot rule out pre-analytical factors, a sample issue, or normal assay performance.Based on the investigation, no product problem was identified and the customer is operational.Section h6 results and conclusion codes were updated to reflect the additional information.

• Brand Name: ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAY
• Type of Device: AHBS2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10115643
• MDR Text Key: 209636224
• Report Number: 1219913-2020-00139
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414591407
• UDI-Public: 00630414591407
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2021
• Device Model Number: N/A
• Device Catalogue Number: 10698706
• Device Lot Number: 122
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR