MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1300 ANALYZER

Model Number ATELLICA IM 1300 ANALYZER

Device Problem High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted siemens to report that one falsely elevated troponin i (tnih) patient sample result was obtained on an atellica im 1300 analyzer.The customer indicated the initial falsely elevated troponin i result was inconsistent with previous results.Siemens is investigating the event.

Event Description

One falsely elevated troponin i (tnih) patient sample result was obtained on an atellica im 1300 analyzer.The discordant result was not reported to the physician.The same sample was repeated twice on the same analyzer and lower results were obtained.The repeat results from the original sample were reported as the correct results.There are no known reports of patient intervention or adverse health consequences due to the event.

Manufacturer Narrative

The initial mdr 2432235-2022-00399 was submitted on 28-dec-2022.Additional information (19-jan-2023): siemens reviewed the instrument log files for the impacted sample.A review of the reagent and sample trace files did not find evidence of a hardware issue impacting the delivery of the troponin reagents or the sample.Pre-analytical variables or a sample specific issue were potentially contributing factors to the falsely elevated troponin i (tnih) result.The cause of the falsely elevated tnih result is unknown.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.Section h6 adverse event problem codes were updated.Corrected information: section d4.Catalog # was corrected from blank to 11066001.Section e1 city: was corrected from (b)(6).Section e1 post office or zip code: was corrected from (b)(6).

• Brand Name: ATELLICA IM 1300 ANALYZER
• Type of Device: ATELLICA IM 1300 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 16062845
• MDR Text Key: 307577856
• Report Number: 2432235-2022-00399
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATELLICA IM 1300 ANALYZER
• Device Catalogue Number: 11066001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 69 YR
• Patient Sex: Male