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

Model Number ADVIA CENTAUR XPT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer's site.The service was performed over multiple visits.The cse found no system issues.The cse checked the wash manifold, aspiration of probe 1,2,3 and 4, vacuum pump, aspiration performance, dispense performance, sample syringe and diluter and verified that the volumes were accurate and consistent , and checked reagent packs, incubation ring magnet, acid and base dispense, which were acceptable.The cse verified that the luminometer was dry and clean.The cse performed luminometer darkcounts and results were acceptable.The cse tested dry, wet water, and wet wash and provided results, which were acceptable.The cse performed precision testing of 30 replicates to verify precision of estradiol, psa, and vitamin b12, which were acceptable.The cause of the discordant estradiol result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.Mdr 2432235-2017-00578 was filed for the same event.Mdr 2432235-2017-00582 was filed for the same event.

Event Description

Inconsistent estradiol results were obtained, between the initial and repeat runs, on one patient sample on a advia centaur xpt instrument.The sample was repeated twice on the same instrument, resulting higher than the initial result.It is unknown which result was discordant and if the result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant estradiol result(s).

Manufacturer Narrative

The initial mdr 2432235-2017-00578 was filed on oct 26, 2017.Corrected information (10/27/2017): the initial estradiol result was discordant and the repeat results were considered the correct results and were reported to the physician(s).This information has been updated.Additional information (10/27/2017): a siemens headquarter support center (hsc) specialist reviewed the event and concluded that while there may have been a system issue that corrected during the system checks , no system issue could be identified.The cause could not be determined.Mdr 2432235-2017-00578_s1 was filed for the same event.Mdr 2432235-2017-00582_s1 was filed for the same event.

Event Description

The initial estradiol result was discordant and the repeat results were considered the correct results and were reported to the physician(s).

Manufacturer Narrative

(b)(4).Additional information (nov.15, 2017): siemens has developed a new gas spring design.Siemens customer service engineers are replacing all gas springs with the new gas spring design during upcoming service visits.On dec.4, 2017, siemens issued a customer notification to customers whose systems have not yet been updated with the new spring design to announce the new gas spring design and remind them that the original gas spring may lose its effectiveness and fail to support the cover in its full or partially open position until their system is updated with the new gas spring design.Customer notification 10817522, rev.B was sent to customers in the us on dec.4, 2017 and customer notification 10817521, rev.B, was sent to customers outside the us in december 2017.

• Brand Name: ADVIA CENTAUR XPT
• Type of Device: ADVIA CENTAUR XPT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown, ny NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, co, dublin ; EI
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6981499
• MDR Text Key: 90970704
• Report Number: 2432235-2017-00583
• Device Sequence Number: 0
• Product Code: CHP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K041133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XPT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2016
• 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