MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR TESTOSTERONE II (TSTII); TESTOSTERONE IMMUNOASSAY

Model Number N/A

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

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

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

The validation/method comparison was performed in parallel with fresh samples for both the testosterone ii (tstii) and testosterone (tsto) assays.The data was generated for validation purposes only.The customer is now using the testosterone ii (tstii) assay to generate patient results and is no longer using the testosterone (tsto) assay.The cause for the discordant testosterone results is unknown.Siemens healthcare diagnostics is investigating.

Event Description

Discordant advia centaur testosterone ii (tstii) results were obtained during validation/method comparison when compared to the advia centaur testosterone (tsto) results.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant testosterone ii (tstii) results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2016-00264 on january 04, 2017.On 01/05/2016 correction: the date of event was (b)(6) 2016.The date received by the manufacturer was 12/15/2016.On 01/06/2016 additional information: the advia centaur testosterone ii (tstii) assay has been aligned to the cdc hormone standardization (host) program.Tstii also demonstrates improved lower end sensitivity and precision.Customers will observe a difference in results based on these changes.The customer should expect low patient values to run lower on tstii and high patient values to run higher on tstii.Internal correlation data (n=128 in range of 8.60-1394 ng/dl) demonstrates an overall bias of <10%.The data generated by siemens is similar to what's been represented in the customer data.The tstii assay is also standardized to the cdc lc-ms/ms method.Customer bulletin 11222821, rev.B, introducing the advia centaur testosterone ii and standardized shbg assays on the advia centaur, xp and xpt systems was issued september 2016.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR TESTOSTERONE II (TSTII)
• Type of Device: TESTOSTERONE IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 6223279
• MDR Text Key: 63915729
• Report Number: 1219913-2016-00264
• Device Sequence Number: 1
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2017
• Device Model Number: N/A
• Device Catalogue Number: 10696862
• Device Lot Number: 001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1