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

Model Number	ADVIA CENTAUR XP
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to inform that quality control (qc) results were within the range, and other patient samples and testing were not affected on the advia centaur xp instrument.The reagent lots that were used by the customer had valid calibrations.Samples spin for 6 minutes at 4400 revolutions per minute (rpm).The ccc dispatched a siemens customer service engineer (cse) to the customer site.A total service call was performed, and no issues were noted.The cse performed maintenance and cleaned residue found in the base probe and adjusted the reagent (r1 and r2) probe positions.The performance of the waste vacuum, acid/base dispense, wash/aspirate probes, and dark count testing were verified, and no issues were noted.The instrument was operational, and the customer ran the same patient sample ten times, and all patient samples recovered <2 miu/ml.Siemens and the customer monitored the performance of the instrument, and there was no recurrence of the event.Siemens evaluated the event and confirmed that other analytes run on the same sample resulted as expected.The discordant result is not reproducible, and siemens required no further testing.Precision on the patient sample run post service was acceptable.The cause of the discordant total hcg result, on one patient sample, on the advia centaur xp instrument is unknown, and preanalytical factors such as the quality and handling of the sample cannot be ruled out from the reported event.The system is performing according to specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant (positive) total human chorionic gonadotropin (total hcg) result was obtained on an advia centaur xp instrument.The discordant result was reported and questioned by the physician(s) at the fertility treatment center.The same sample and instrument were used to perform repeat testing.The repeat result was lower (negative) and matched with the expectations for the patient.The customer issued a corrected report.There are no reports of patient intervention or adverse health consequences due to the discordant total hcg result.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: ADVIA CENTAUR XP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8743969
• Report Number: 2432235-2019-00225
• Device Sequence Number: 19492496
• Product Code: JJE
• UDI-Device Identifier: 00630414585475
• UDI-Public: 00630414585475
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141999
• 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): 06/28/2019

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
• Operator of Device: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Device Catalogue Number: 10471899
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1