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

Model Number ADVIA CENTAUR CP

Device Problem Device Issue (2379)

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

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) because of (b)(6) inconsistent patient results.A siemens customer service engineer (cse) was dispatched to the customer's site.While troubleshooting the instrument, the cse performed a total service visit including preventive maintenance.The cse replaced the sample syringe.The cse ran quality control (qc), resulting within specification.The cse ran patient samples comparison prior to and after maintenance service, resulting satisfactory following service maintenance.The cause of the inconsistent rubella igg results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.Mdrs 2432235-2017-00493 and 2432235-2017-00499 were filed for the same event.

Event Description

One patient sample tested (b)(6) for (b)(6)on an advia centaur cp instrument.The positive result was reported to the physician(s).Two days later, the sample was repeated four times, resulting positive once and negative three times.It is unknown which result is correct.There are no reports of patient intervention or adverse health consequences due to the inconsistent rubella igg results.

• 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; neuwiesenstrasse 4; beringen, 8222; registration #: 3008494306, ; SZ
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6822594
• MDR Text Key: 83749349
• Report Number: 2432235-2017-00500
• Device Sequence Number: 0
• Product Code: LFX
• 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: 08/25/2017

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 CP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2017
• Initial Date FDA Received: 08/25/2017
• 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