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

Model Number ADVIA CENTAUR XP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The customer stated that no doctors have questioned any results and there were no corrected reports.The customer handles reagents, patients, and quality controls according to manufacturer's recommendations.In addition, the reagent appeared homogenous and all maintenance was up to date.The customer provided ccc with calibration and quality control data, which indicated calibration was valid and results were within range.The customer ran master curve material, and values were with range.The customer then ran a correlation study on atg with a previous reagent lot, and verified that the current reagent lot was acceptable.The customer declined service.The cause of the discordant atg result is unknown.All other patient samples tested for atg resulted as expected.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A patient sample was drawn on (b)(6) 2016 and was frozen.The customer stated the sample appeared slightly hemolyzed but had no bubbles or clots.The sample was thawed out on (b)(6) 2016, mixed and run from the primary tube on an advia centaur xp instrument, and an elevated anti-thyroglobulin (atg) result, above the assay range, was obtained.The result was not reported to the physician(s).The sample was repeated from the primary tube and auto diluted 1:5 and manually diluted 1:2 on the same day, resulting as "over diluted".The sample was repeated undiluted on the same instrument, resulting lower.There was no sample left for testing, causing delay in reporting a result for the patient.The customer stated that there was harm to the patient due to the delay in reporting the result but did not have any further information on the harm, other than the patient requiring a redraw.

• 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; chapel lane; swords, co., dublin el, ; SZ
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5462172
• MDR Text Key: 39089173
• Report Number: 2432235-2016-00100
• Device Sequence Number: 0
• Product Code: JNL
• 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: 02/02/2016

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: 02/02/2016
• Initial Date FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2010
• 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