MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) ASSAY; TROPONIN IMMUNOASSAY

Model Number N/A

Device Problem Clumping in Device or Device Ingredient (1095)

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

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

After obtaining frequent reagent probe volume check errors on a single readypack of advia centaur cp tni-ultra reagent, the customer visually inspected the readypack and observed agglutination of the non-magnetic latex particles.The customer performed aggressive mixing of the readypack and the non-magnetic latex particles did not go back into solution.The system could not aspirate the reagent.The customer confirmed that the system could aspirate other reagents (bnp and ckmb).Siemens asked that the readypack be returned to siemens for evaluation.The loading reagents section of the instructions for use states: "note: mix all primary reagent packs by hand before loading them onto the system.Visually inspect the bottom of the reagent pack to ensure that all particles are dispersed and resuspended.For detailed information about preparing the reagents for use, see the system operator's guide.".

Event Description

The customer placed a readypack of advia centaur cp troponin ultra (tni-ultra) on the system and obtained multiple volume check errors with the readypack.Advia centaur cp tni-ultra results could not be generated.The laboratory manager stated there was a delay in testing patient results because they did not have any other readypacks of advia centaur cp tni-ultra available.There are no reports that treatment was altered or prescribed or adverse health consequences due to the delay in reporting advia centaur cp tni-ultra results.

Manufacturer Narrative

Mdr 1219913-2016-00062 was submitted on march 22, 2016 reporting a readypack of advia centaur cp troponin ultra that was placed on the system and multiple volume check errors were observed on the readypack.Advia centaur cp tni-ultra results could not be generated.The customer noted that there was a delay in testing because there no other reagents available.May 2, 2016 - additional information siemens received a readypack of advia centaur cp troponin ultra from the customer.The returned readypack shows no visual abnormality compared to a readypack from siemens' retains.The ancillary reagent well which contains non-magnetic latex particles was in solution.This is the reagent where the customer noted the agglutinated reagent.Siemens cannot confirm the complaint.Shipping and handling of the readypack cannot be ruled out as the cause of the agglutinated reagent.

• Brand Name: ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) ASSAY
• Type of Device: TROPONIN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 5086604381
• MDR Report Key: 5551813
• MDR Text Key: 42036537
• Report Number: 1219913-2016-00062
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K053020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2016
• Device Model Number: N/A
• Device Catalogue Number: 02789602
• Device Lot Number: 010099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1