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

Model Number ADVIA CENTAUR XP

Device Problem Computer Operating System Problem (2898)

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

Event Date 04/24/2015

Event Type  malfunction  

Event Description

Intact parathyroid hormone (ipth) testing was delayed for one intraoperative patient.The patient was undergoing parathyroid surgery.The operator could not run the patient sample on an advia centaur xp instrument due to a software crash.After reboot, it took an additional 40 minutes until the system was ready to run the patient sample.Thus the surgery took an additional 90 minutes to complete due to the delay in obtaining ipth testing results.There are no known reports of patient intervention or adverse health consequences due to delay in testing the ipth patient sample.

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The customer stated that they were having issues with the turn disc at the external sample position of the system, which generated a lot of error messages.During this time, the customer loaded the sample for the measurement of ipth on the system and experienced a software crash.The customer rebooted the system and ran the patient sample.As a preventive measure, the customer has changed their standard operating procedure.In the future, before an intraoperative sample is run in frontload, the system must be disconnected from automation.The cause of delay in testing the ipth result was related to the software crash.The instrument is performing according to specifications.No further evaluation of the device is required.

Manufacturer Narrative

The initial mdr 2432235-2015-00269 was filed on may 28, 2015.Additional information (05/06/2015): use of the advia centaur intact parathyroid hormone (ipth) assay on intraoperative samples is off-label use.As per the instructions for use for advia centaur ipth, this assay is for in vitro diagnostic use in the quantitative determination of ipth in edta plasma or serum using the advia centaur, advia centaur xp, and advia centaur xpt systems.This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.

Manufacturer Narrative

The initial mdr 2432235-2015-00269 was filed on may 28, 2015.The first supplemental mdr 2432235-2015-00269_s1 was filed on may 29, 2015.Additional information (08/07/2015): in addition to the off-label use noted in supplemental report #1, the following was found related to the instrument.A siemens headquarters support center (hsc) specialist reviewed the instrument data and indicated that there is no evidence that the cause was related to a software crash.The hsc specialist stated that one of the samples had three tests associated with it and was repeatedly processed 55 times causing the front loaded ipth sample not to run.The ipth sample was eventually rescheduled and the result was obtained.The cause of delay in testing the ipth result on one patient sample is unknown.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, co., dublin ; EI
• Manufacturer Contact: michael metz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242223
• MDR Report Key: 4803508
• MDR Text Key: 5893525
• Report Number: 2432235-2015-00269
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 08/07/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2011
• 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