MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP TOTAL HCG

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reports a single non-reproducible discordant patient result on advia centaur total hcg (thcg) reagent lot 029312.The initial thcg result when the sample was initially tested was positive for pregnancy.The result was questioned by the physician and the same sample was repeated and resulted negative for pregnancy.Advia centaur thcg reagent lot 029312 calibration and qc results were acceptable.Service was sent and a total service check was performed, no instrument issues were identified.Advia centaur thcg precision was evaluated post service, 3 negative patient samples and 2 levels of controls in replicates of 5 were run.The advia centaur thcg precision was found to be acceptable.The customer reports that post service the advia centaur thcg assay is performing within specification.Siemens cannot definitively determine the cause of this discrepant result.Contributing factors such as pre-analytical variables cannot be ruled out.Pre-analytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.Quality control was in range and no issues were noted with other patient samples indicating that the instrument and reagents were performing acceptably.Repeat of the same sample yielded expected results.Based on the results of the investigation, return of the patient sample is not warranted.A product issue has not been identified.The instructions for use 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 limitations section states: "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 or Problem Description
Customer obtained an elevated advia centaur xp total hcg (thcg) result that was questioned by the physician.The sample was repeated on the advia centaur xp thcg assay and resulted lower.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp thcg result.

• Brand Name: ADVIA CENTAUR XP TOTAL HCG
• Common Device Name: TOTAL HCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10252027
• Report Number: 1219913-2020-00168
• Device Sequence Number: 11476294
• Product Code: JHI
• UDI-Device Identifier: 00630414505176
• UDI-Public: 00630414505176
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K925277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2020
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 029312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1