MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAY; HBSAG CONFIRMATORY IMMUNOASSAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report discordant non confirmed advia centaur xp hbsag confirmatory results obtained on patient samples.A siemens customer service engineer (cse) was dispatched to the customer site for instrument inspection.The cse performed reagent, sample, ancillary probe calibrations and checked aspiration and probe dispensing.The customer performed an assay calibration, ran over 30 test samples successfully.Additionally, four reactive hbsag samples were confirmed with hbsag confirmatory.It was observed that the hbsag confirmatory testing performed by the customer were not tested initially as neat (undiluted) samples.The customer states no further issues post service or discordant patient results.Siemens healthcare diagnostics is investigating.The hbsag instruction for use (ifu) under the interpretation section states the following: "if the sample is >50 or flagged as "> index range," the specimen is reactive for hbsag and no further testing is required." the hbsag confirmatory instruction for use (ifu) under the testing algorithm table for the interpretation of repeat reactive samples references; undilute, 1:50 dilution and 1:2500 dilution of samples.Mdr 1219913-2020-00083 (04-feb-2020 result), mdr 1219913-2020-00084 (05-feb-2020 result), mdr 1219913-2020-00085 (10-feb-2020 @ 10:50 result), mdr 1219913-2020-00087 (11-feb-2020 result), and mdr 1219913-2020-00088 (12-feb-2020 result) were filed for this incident.

Event Description

Advia centaur xp hbsag confirmatory non confirmed results were obtained by the customer on patient samples and considered discordant compared to positive hbsag results.The positive hbsag results were reported to the physician(s).The customer performed additional hbsag confirmatory testing that confirmed the positive hbsag test results.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xp hbsag confirmatory results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00086 report on 28-feb-2020.02-mar-2020 - additional information: siemens has reviewed the instrument and event data including actions performed by the customer service engineer (cse).Based on the information provided, the cause of the discordant result could not be determined, however the issue was resolved with probe calibration and maintenance as part of normal routine instrument troubleshooting.03-mar-2020 - additional information: the customer is using the 1:50 dilution when testing samples with the advia centaur xp hbsag confirmatory assay with multi-diluent 2 kit lot 73059.The customer should be following the advia centaur xp hbsag confirmatory instructions for use (ifu) and testing the samples neat (undiluted) before using dilutions to reduce the risk of erroneous not confirmed results.In summary, the cse performed all reagent, sample, and ancillary probe calibrations, as well as checked the aspiration and dispenses of probes.The customer states no further issues post service and they are satisfied with assay performance.The cause of the erroneous not confirmed results observed by the customer was due to an issue resolved with routine instrument troubleshooting.Based on the investigation, no product problem was identified.Mdr 1219913-2020-00083 supplemental report 1, mdr 1219913-2020-00084 supplemental report 1, mdr 1219913-2020-00085 supplemental report 1, mdr 1219913-2020-00087 supplemental report 1, and mdr 1219913-2020-00088 supplemental report 1 were filed for the same event.

• Brand Name: ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAY
• Type of Device: HBSAG CONFIRMATORY IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9770910
• MDR Text Key: 221282301
• Report Number: 1219913-2020-00086
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 10309058
• Device Lot Number: 408541511
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1