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

Model Number ADVIA CENTAUR CP

Device Problem Mechanical Problem (1384)

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

Event Date 08/14/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer.After evaluation of the instrument and instrument data, the cse adjusted aspiration probe 2 as it was too high and was not fixed to the vertical rack.The cse checked the acid and base dispense volumes, cleaned the luminometer, and checked the wash station, injector, distribution volume, and connectors.The cse replaced the wash 1 pump due to a crack.Quality controls were within range.The cause of the discordant, (b)(6) result is unknown, as repeat testing on the same instrument resulted as expected.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, (b)(6) antibodies to (b)(6) surface antigen ((b)(6)) result was obtained on one patient sample on an advia centaur cp instrument.The discordant result was reported to the physician(s).Two weeks later, a new sample was obtained from the patient and tested on the same instrument, resulting (b)(6).The customer then centrifuged and repeated the original sample on the same instrument, and the result was also (b)(6).The corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant,(b)(6) result.

Manufacturer Narrative

The initial mdr 2432235-2015-00414 was filed on september 25, 2015.Additional information (10/23/2015): in an investigation conducted by siemens healthcare it has been determined that the wash 1 pump which was replaced is suspected to be the cause of the (b)(6) result.The assessment is based on the wash sequence that is specified for the (b)(6) assay, which requires a three wash sequence to be performed.In this case, the wash 1 pump delivers wash 1 to dispense port 1 and wash displacement port.

• Brand Name: ADVIA CENTAUR CP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; registration #: 3008494306; gewerbestrasse 6; neuhausen am rheinfall, 8212 ; SZ 8212
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5103914
• MDR Text Key: 26780327
• Report Number: 2432235-2015-00414
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• 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: Followup
• Report Date: 08/31/2015
• 2 Devices were Involved in the Event: 1 2

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 CP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: No
• 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