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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT STAT HIGH SENSITIVE TROPONIN-I; IMMUNOASSAY METHOD, TROPONIN SUBUNIT
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ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT STAT HIGH SENSITIVE TROPONIN-I; IMMUNOASSAY METHOD, TROPONIN SUBUNIT Back to Search Results
Catalog Number 03P25-77
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2023
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 3p25 has a similar product distributed in the us, list number 2r98.
 
Event Description
The customer observed a falsely depressed architect stat high sensitive troponin-i result for a patient diagnosed with myocarditis.The following data was provided: initial result = 0.0 pg/ml, repeat = 0.0 pg/ml, repeat with two other methods = positive no impact to patient management was reported.
 
Manufacturer Narrative
The complaint investigation for falsely depressed architect stat high sensitive troponin-i results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, labeling review, and in-house testing.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.A search for similar complaints did not identify an increase in complaint activity for lot 55246ud01.A review of tracking and trending did not identify any related trends regarding commonalities for lot number 55246ud01 and issue.Device history record review for lot 55246ud01 did not identify any nonconformances, potential nonconformances or deviations associated with the complaint issue.In-house accuracy testing was completed with a retained kit of lot number 55251ud00 (lot number 55251ud00 contains the same bulk material as lot number 55246ud00).All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency of the architect stat high sensitive troponin-i for lot 55246ud00 was identified.
 
Event Description
The customer observed a falsely depressed architect stat high sensitive troponin-i result for a patient diagnosed with myocarditis.The following data was provided: initial result = 0.0 pg/ml, repeat = 0.0 pg/ml, repeat with two other methods = positive no impact to patient management was reported.
 
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Brand Name
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
Type of Device
IMMUNOASSAY METHOD, TROPONIN SUBUNIT
Manufacturer (Section D)
ABBOTT IRELAND DIAGNOSTICS DIVISION
lisnamuck
co. longford
longford N39E9 32
EI  N39E932
Manufacturer (Section G)
ABBOTT IRELAND DIAGNOSTICS DIVISION
lisnamuck
co. longford
longford N39E9 32
EI   N39E932
Manufacturer Contact
nicole jenne
max-planck-ring 2
post market surveillance
wiesbaden 65205
GM   65205
6122582960
MDR Report Key18313961
MDR Text Key330942953
Report Number3005094123-2023-00368
Device Sequence Number1
Product Code MMI
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/12/2024
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
Device Operator Health Professional
Device Expiration Date02/01/2024
Device Catalogue Number03P25-77
Device Lot Number55246UD01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/30/2023
Initial Date FDA Received12/12/2023
Supplement Dates Manufacturer Received01/09/2024
Supplement Dates FDA Received01/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/26/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARC I2000SR INST, 03M74-02, ISR64055; ARC I2000SR INST, 03M74-02, ISR64055
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