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 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

The customer observed that the discordant result was reported two seconds after a diluted sample with a value greater than 135,000miu/ml.A siemens field service engineer (fse) was sent to the customer site for system inspection.The fse performed decontamination of the lines of acid, base and wash1 with h2o2 10%.After decontamination and daily maintenance, performance monitoring with controls was performed.The alignments of probes were verified.Dirt accumulated in stations 3 and 4 and in their probes was identified.The stations were cleaned.Siemens healthcare diagnostics is investigating.The ifu states in the interpretation of results section: "interpretation of results 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).If an aberrant or abnormal result, as defined by the laboratory protocol, occurs, laboratory personnel should first make certain that the system is performing and is operated and maintained in accordance with the product labeling.The user should then follow the laboratory protocol for advising the clinician of a result that appears to have deviated from the norms established by the laboratory.Test results alone are not diagnoses of medical conditions.For example, low titer elevations of hcg can occur in normal non-pregnant subjects.A physician's diagnosis involves evaluation of the test result in conjunction with, and in the context of, the patient's medical history, physical examination, and other test results-sometimes in consultation with other medical experts.".

Event Description

A false positive advia centaur xpt total hcg result was obtained on a patient sample.The patient sample was repeated on the same instrument and the result was negative.The same sample was repeated again on the advia centaur xp and the result was negative.A corrected report was issued.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 1219913-2019-00122 on june 28, 2019.07/19/2019 additional information: siemens reviewed the event data and service report.The customer service engineer (cse) was dispatched on site to troubleshoot the issue.According to the service report, the cse noticed "dirt" accumulation at the rinse station 3 and 4.The cse proceeded to clean the rinse stations, and their probes.The cse further performed daily maintenance activity and a full system decontamination with h2o2 10% in the fluidic lines of acid, base and wash1.Verified instrument performance and controls and no further issues found.Based on the information provided, the probable cause was due to contamination of the instrument since after a full system decontamination and performing daily maintenance, the issue was resolved.The cse also found "dirt" accumulation at the rinse station which is evidence that proper maintenance was not followed.The operator should perform "clean probe rinse stations" activity in order to "clean the rinse station for the three reagent probes and the ancillary probe when you can see pragmatic particles on the rinse stations." as per "advia centaur xpt as-needed maintenance instruction".There is also no evidence of a product nonconformance since the service done is routine troubleshooting.The instrument is performing within specifications.No further evaluation of the device is required.

• 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 10591 5097
• MDR Report Key: 8743721
• MDR Text Key: 209597804
• Report Number: 1219913-2019-00122
• 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
• Report Date: 07/30/2019

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: 11/16/2019
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 31956305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 07/19/2019
• Supplement Dates FDA Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR