MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM TROPONIN I ULTRA (TNI-ULTRA); TROPONIN IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the high results is unknown.Siemens healthcare diagnostics is investigating.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." mdr 1219913-2020-00007 (patient 2) was filed for the same event.
Event or Problem Description
Discordant high atellica im 1300 analyzer troponin i ultra (tni-ultra) results were obtained for two patient samples.The results were reported to the physician.The patient samples were repeated and the results were lower.The patients were admitted to the hospital based on the initial high result.No treatment was altered or prescribed based on the results.There were no reports of adverse health consequences due to the discordant high atellica im tni-ultra results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2020-00006 on january 21, 2020 reporting an elevated troponin i ultra (tni-ultra) result on the atellica im 1300 analyzer that was not reproducible.January 21, 2020 - additional information: while the exact root cause of the falsely elevated results cannot be determined, siemens cannot rule out a system maintenance issue or preanalytical sample handling as the probable cause.Qc was within limits at the time of the patient results.A customer service engineer aligned the sample probe to the track and performed a decontamination on the acid/base system.Post service there have been no further instances of falsely elevated tni-ultra results.Additionally, the customer uses a statspin 3 minute plasma /5 minute serum centrifuge protocol for all emergency room samples.No product performance issue is confirmed.The customer is operational.Mdr 1219913-2020-00007 and mdr 1219913-2020-00007 supplemental report 1 was filed for the same event.

• Brand Name: ATELLICA IM TROPONIN I ULTRA (TNI-ULTRA)
• Common Device Name: TROPONIN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9611560
• Report Number: 1219913-2020-00006
• Device Sequence Number: 2738499
• Product Code: MMI
• UDI-Device Identifier: 00630414600093
• UDI-Public: 00630414600093
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K053020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995696
• Device Lot Number: 167
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1