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

Model Number	ADVIA CENTAUR XP
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer's site and inspected the instrument.The cse confirmed that the instrument was operating correctly.The customer changed from lot number 184 to lot number 192.The customer had reported that the situation has improved, and repeatability is now in positive controls.Instrument will be checked again and information will continue to be monitored and collected.Siemens is investigating the event.
Event or Problem Description
A (b)(6) patient result was obtained on an advia centaur xp instrument.The initial result was reported to the physician(s) and questioned.The same sample was repeated three times on an alternate instrument.The repeated results were reported, to the physician(s).Physician(s) was unsure of the correct result.There are no known reports of patient intervention or adverse health consequences due to the discordant results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2019-00371 on (b)(6) 2019.Siemens further investigated the event and determined the sample was collected in a becton dickinson tube, allowed to clot for 30 minutes, and centrifuged for 5 minutes at 4000 revolutions per minute (rpm).For retesting, the sample was decomplemented by heat at 37 degrees celsius, and centrifuged again for 30 minutes.The tube manufacturer recommends the tubes are centrifuged for 10 minutes, or 15 minutes, if a fixed angle centrifuge is used.There is potential that the initial centrifuge time was not sufficient.Additionally, the advia centaur xp/xpt hbsii ifu states, at a 95% confidence interval, for specificity (after retesting) as 99.78 to 99.97% so false positive results can be expected.Siemens could not find any issue with the instrument.Siemens could not rule out pre-analytical factors or a sample issue.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: ADVIA CENTAUR XP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 9216358
• Report Number: 2432235-2019-00371
• Device Sequence Number: 2483884
• Product Code: JJE
• UDI-Device Identifier: 00630414585475
• UDI-Public: 00630414585475
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K971418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR