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 09/11/2017

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 2432235-2017-00583 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 was reported.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 2432235-2017-00583_s1 was filed for the same event.

Event Description

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

• 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: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6981494
• MDR Text Key: 90962632
• Report Number: 2432235-2017-00582
• 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
• Report Date: 11/01/2017
• 2 Devices were Involved in the Event: 1 2

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: 10/27/2017
• 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