MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT STAT HIGH SENSITIVE TROPONIN-I; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number 03P25-27

Device Problem Low Test Results (2458)

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

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

Completed information for patient identifier: sids (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely depressed architect stat high sensitive troponin-i results for three patients when compared to their ckmb results.The following data was provided (reference ranges: male  ckmb is <3.1 ug/l and troponin is <34.2 ug/l; female  ckmb is <5.2 ug/l and troponin is <15.6 ug/l): (b)(6) 2021 sid (b)(6) male patient: ckmb = 51.20 ug/l, troponin = 27.046 ug/l.(b)(6) 2021 sid (b)(6) female patient: ckmb = 46.37 ug/l, troponin = 9.994 ug/l.(b)(6) 2021 sid (b)(6) male patient: ckmb = 40.51 ug/l, troponin = 20.052 ug/l no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely depressed architect stat high sensitive troponin-i results included a search for similar complaints, and the review of complaint text, trending data, labeling, device history records, and field data review.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review on lot 27306ud00 did not show any related potential non-conformances, deviations, or non-conformances.The overall performance of architect stat high sensitive troponin-i was reviewed using field data from customers worldwide.The median population result for the lot is within established baselines and comparable with all other lots in the field and confirms no systemic issue for this lot.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect stat high sensitive troponin-i for lot number 27306ud00 was identified.Section d4 lot no was updated from 26305ud00 to 27306ud00 section d4 catalog no was updated from 03p25-37 to 03p25-27.

• Brand Name: ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12519953
• MDR Text Key: 272938950
• Report Number: 3005094123-2021-00181
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K191595
• Number of Events Reported: 1
• 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: 11/16/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2021
• Device Catalogue Number: 03P25-27
• Device Lot Number: 27306UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 09/23/2021
• Supplement Dates Manufacturer Received: 11/02/2021
• Supplement Dates FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(4)