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

Model Number ADVIA CENTAUR XP

Device Problem Mechanical Problem (1384)

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

Event Date 11/06/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse replaced the photomultiplier assembly, two way valve, 2ml diluter assembly, capacitance sensor assembly and tubing.Precision was run, resulting in fliers.The cse found the power connection to aspirate probe 1 was corroded, and repaired the connection.The cse replaced the sample syringe, wash manifold, 5ml diluter, and valves 1 and 4.The cse checked the acid and base, and dispense and aspiration of the wash manifold.The cse adjusted reagent probe 1 at the cuvette bottom.Patient sample precision was then acceptable.The customer ran quality controls which failed for levels 2 and 3.The cse replaced the sample and ancillary probe tubing, diluters and valves, and sample plunger and nozzle.The cse decontaminated the acid and base, and replaced the ancillary bubble detector.Precision was run and coefficients of variations were out of range.The cse discovered reagent probe 2 had leaked onto the reagent probe 2 sensor board.The cse replaced board and arm assembly, and calibrated to the ring and wash stations.The cse replaced waste probe valve 28, fluidics manifold valves and tubing, photomultiplier, base pump, and wash manifold tubing.Multiple assays were calibrated and precision were run, resulting within range.Quality controls were run, resulting within range.The cause of the discordant ca 27.29 results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant cancer antigen 27.29 (ca 27.29) results were obtained on patient samples on an advia centaur xp instrument.The discordant results were reported to the physician(s).The samples were repeated twice, five days later, on the same instrument, resulting higher for some patient and lower on others.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant ca 27.29 results.

• 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 limited; registration number: 8020888; chapel lane, swords, co., dublin ; EI
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown 10591 ; 9145243105
• MDR Report Key: 5275217
• MDR Text Key: 32982930
• Report Number: 2432235-2015-00573
• Device Sequence Number: 0
• Product Code: MOI
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2008
• 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