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

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported a delay in availability of troponin testing due to insufficiency of local atellica im troponin i ultra (tni-ultra) reagent supply.There is no allegation of product malfunction, and no indication of adverse effects on patient treatment.As the customer's reagent supply was exhausted and immediate resupply was not available, the customer had to send samples to an external lab for troponin testing.The exact duration of the delay was not specified, but there is no report of effects on patient management or of patient diversion to alternate facilities.This event is being reported conservatively due to the potential risk associated with the lack of local troponin testing capability.No patient harm was reported, and no product malfunction was identified.No further action is required.
Event or Problem Description
A customer's on-hand atellica im troponin i ultra (tni-ultra) assay reagents reached their expiration dating before resupply was obtained.As a result, the customer reported a delay in the availability of troponin testing.There is no allegation of any effect on patient treatment, and no patient harm has been reported.

• Brand Name: ATELLICA IM TROPONIN I ULTRA (TNI-ULTRA)
• Common Device Name: TROPONIN I IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 12139743
• Report Number: 1219913-2021-00374
• Device Sequence Number: 1533563
• Product Code: MMI
• UDI-Device Identifier: 00630414600093
• UDI-Public: 00630414600093
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K053020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: 10995696
• Device Lot Number: 182
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1