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

Model Number ADVIA CENTAUR XP

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/13/2015

Event Type  malfunction  

Event Description

Imprecise cardiac troponin i (tni-ultra) results were obtained on multiple patient samples when run in duplicate on an advia centaur xp instrument.The imprecise results were not reported to the physician.It is unknown which results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the imprecise tni-ultra results.

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.The cse evaluated the instrument and performed a total service call.A siemens field application specialist (fas) reviewed the instrument data, which indicated that the imprecise tni-ultra results were associated with samples having a shorter stand period prior to the centrifugation.The cause of imprecise tni-ultra results on multiple patient samples is unknown.Siemens healthcare diagnostics is investigating the issue.

Manufacturer Narrative

The initial mdr 1226181-2015-00237 was filed on may 12, 2015.Additional information (05/19/2015): a siemens customer service engineer (cse) specialist re-visited the customer site.The cse replaced the photomultiplier tube (pmt) and the precision improved.The customer did not obtain anymore imprecise results.The cause of imprecise tni-ultra results on multiple patient samples is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Manufacturer Narrative

The initial mdr 2432235-2015-00237 was filed on may 12, 2015.The first supplemental mdr 2432235-2015-00237_s1 was filed on 05/29/2015.Additional information (04/20/2015): the first supplemental mdr contained incorrect information.The photomultiplier tube was not replaced on this instrument.It had been replaced on a different instrument at the customer site.Upon re-visit, a siemens customer service engineer (cse) specialist replaced the wash 1 and acid base fluids, as well as the reagent.The customer has not obtained any more discordant results.The cause of imprecise tni-ultra results on multiple patient samples is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.(b)(4).

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, co., dublin ; EI
• Manufacturer Contact: michael metz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242223
• MDR Report Key: 4766112
• MDR Text Key: 16457679
• Report Number: 2432235-2015-00237
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1