MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT TOTAL HCG (THCG)

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

A siemens field service engineer (fse) was sent to the customer site for system inspection (s/n (b)(4)).The fse adjusted the probe position settings.The system has been followed for one week and no false positive results were obtained.Siemens healthcare diagnostics is investigating.The ifu states in the interpretation of results section: "interpretation of results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the ifu states in the limitations section: "all in vitro assays can generate erroneous results, both clinically false positive results (test results suggesting a condition that is absent) and clinically false negative results (test results failing to identify a condition that is present).".

Event Description

A false positive advia centaur xpt total hcg result was obtained on a patient sample upon repeat on another advia centaur xpt.The initial result for the patient was negative.The patient sample was repeated on the same instrument and the result was negative.The result was reported as negative.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant total hcg result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00062 on february 13, 2020.Siemens filed the mdr 1219913-2020-00062 supplemental report 1 on march 12, 2020.Siemens filed the mdr 1219913-2020-00062 supplemental report 2 on april 13, 2020.May 08, 2020 additional information: siemens reviewed the instrument and event data including actions performed by the field service engineer (fse).The fse performed a total service call, adjusted probe positions for sample and reagent probes, replaced the luminometer, o-ring, and dark counts were performed which were high.The fse then replaced the luminometer, and tested dark counts with acceptable results.There have been no further issues since the service performed.Siemens concluded that the cause of the discordant result was due to the malfunction of the luminometer.The issue was resolved with replacement of the luminometer as part of normal routine instrument troubleshooting.Based on the investigation, no product problem was identified.The system is operating as expected.The instrument is performing within specifications.No further evaluation of the device is required.Section h6, the device, method, results and conclusion codes were updated to reflect the additional information.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00062 on february 13, 2020.Siemens filed the mdr 1219913-2020-00062 supplemental report 1 on march 12, 2020.March 20, 2020 additional information: the customer reported a discordant patient result on the advia centaur xpt total hcg assay.The sample initially resulted positive for pregnancy.The customer's internal procedure is to repeat all positive samples on another system.The same sample was repeated on this advia centaur xpt as well as another advia centaur xpt in the laboratory and both results were negative.Quality control from the day of this event was within range.Service was sent for this issue and the sample probe needed to be recalibrated.Following service, the customer monitored total hcg performance and they have not had any further concerns.Siemens cannot definitively determine the cause of this discrepant result.Contributing factors such as sample integrity and/or sample probe misalignment cannot be ruled out.Repeat of the same samples yielded expected results.Based on the results of the investigation, return of the patient samples is not warranted.A potential product issue has not been identified.The field service engineer (fse) replaced the luminometer due to the high reading of the dark count results.It was found that the count readings were in the 40-50 range.All testes were calibrated and checked with acceptable results.Siemens is reviewing the advia centaur xpt s/n (b)(6) service performed as part of the investigation.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00062 on february 13, 2020.February 18, 2020 additional information: details of the field service engineer (fse) reports have been received for the advia centaur xpt s/n (b)(6).Distilled water conductivity was checked.Water quality is good.System vacuum checked.No problems were seen.All incubation ring calibration are done.Sample probe and reagent probe calibrations were adjusted again.Reagent probe water dispense was checked.Water pressure pump was adjusted.Reagent probe water dispense was checked.The volume is normal, 5 ml.Aspirate probe external wash was checked.Washings are normal.Service was given due to signal error 1.Vacuum was checked.The vacuum regulator was replaced even though the problem was not seen.Aspirate probes were checked.Dispensing of reagent probes at the cuvette dispense was checked.No problems were seen.Luminometer was checked.No wetness was seen.Ioniser checked.No problems were seen.Luminometer o-ring was replaced.Dark count was performed.Sd values are high.Luminometer replacement will be made.Dark count will be checked.March 02, 2020 additional "information" from the region: a single device ((advia centaur xpt s/n (b)(6)) produced the erroneous results.The customer repeats every positive/suspicious result for thcg with the same or different device (instrument).When the technical service checked the device, it detected problems in the probe position settings.There was no change on the customer side (preanalytical, sample collection tube type, centrifuge time / speed etc.).The system has been followed for one week, no false positive results were obtained.Siemens healthcare diagnostics continues to investigate.

• Brand Name: ADVIA CENTAUR XPT TOTAL HCG (THCG)
• Type of Device: TOTAL HCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9708574
• MDR Text Key: 201367437
• Report Number: 1219913-2020-00062
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414505176
• UDI-Public: 00630414505176
• Combination Product (y/n): N
• PMA/PMN Number: K925277
• 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: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 18365309
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1