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

Model Number ADVIA CENTAUR XP

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2015

Event Type  malfunction  

Event Description

Discordant, (b)(6) results were obtained on two patient sample on an advia centaur xp instrument.The discordant results were not reported to the physician(s).The sample were repeated on an alternate advia centaur xp instrument.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, (b)(6) results.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse changed the tubing for the sample probe plunger, lubricated the syringe, removed and cleaned the plunger, changed the vertical probe belt, changed the acid and base pumps, and recalibrated the sample probe bottom.The customer is running siemens (b)(6) quality controls every four hours in replicates of ten.The cause of the discordant, (b)(6) result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; registration number: 8020888; chapel lane, swords, co.,; dublin ; EI
• Manufacturer Contact: michael metz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242223
• MDR Report Key: 4743777
• MDR Text Key: 17585082
• Report Number: 2432235-2015-00223
• Device Sequence Number: 1
• Product Code: OBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/07/2015

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
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/30/2010
• 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