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

Model Number ADVIA CENTAUR CP

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens is investigating the event.

Event Description

Discordant, falsely elevated free thyroxine results were obtained on three patient samples on an advia centaur cp instrument.The initial results were not released to the physician(s).The same samples were repeated on the same advia centaur cp instrument, resulting lower.The customer repeated the same sample again on the same advia centaur cp instrument, resulting similarly to the first repeat result.The customer reported out the first repeat result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated free thyroxine results.

Manufacturer Narrative

The initial mdr 2432235-2017-000275 was filed on april 21st, 2017.Additional information (03/31/2017): on 3/31/2017, a siemens customer service engineer (cse) found dirt in the sample probe air line and cleaned the line and transducer.The cse performed quality controls (qc) with results in range.The system was returned to operation.On 04/04/2017 the cse returned to the site and performed a ring test.The cse checked sample probe, reagent probe, reagent syringe, sample syringe wash station aspirations and inspected the acid, base and wash 1 pumps and verified dispenses.All worked properly.On 04/05/2017 the cse performed the 6 month preventive maintenance and verified that the system is performing to specification.A siemens headquarter support center specialist (hsc) concluded the cse did not find any issues other than the dirt in the sample air line.Dirt in the sample air line would not cause poor precision of the qc as this would cause sample detection error that would stop the test.Free thyroxine 4 is an inverse assay, indicating that there was lower than expected relative light units (rlu) result.Qc precision could be affected if the reagent volume or quality was jeopardized or if there was bleach contamination at the time of the testing.Since the cse could not identify any system issue at the time, this is an isolated incident that corrected itself and could not be identified or confirmed.

• Brand Name: ADVIA CENTAUR CP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; 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: 6514122
• MDR Text Key: 73459932
• Report Number: 2432235-2017-00275
• Device Sequence Number: 0
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K971418
• 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: 06/06/2017

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: 03/28/2017
• Initial Date FDA Received: 04/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2011
• 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