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 10/30/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: sample id (b)(6).This report is being filed on an international product, list number 3p25 that has a similar product distributed in the us, list number 2r98.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a falsely depressed architect stat high sensitive troponin-i result for a (b)(6) male patient that has had a history of elevated troponin-i results previously.The following data was provided (customer¿s reference range: male: less than 34 ng/l, female: less than 16 ng/l): on (b)(6) 2021 sample id (b)(6)= initial troponin result at 10:40 am = 0.0 ng/l, repeated troponin results at 11:06 am and 11:24 am = 39.7, 39.9 ng/l there was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for falsely initially depressed architect stat high sensitive troponin-i result included a search for similar complaints, and the review of complaint text, trending data, labeling, field data, device history records, and in-house testing was completed with a retained kit of the complaint lot.Return testing was not performed as returns were not available.The lot search review did not identify an increase in complaint activity for the issue for the lot.Trending was reviewed and did not identify any trends for the product for the issue.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit stored at the recommended storage condition.All specifications were met indicating that lot 28052ud00 is performing acceptably.Customer field data was used to assess the performance of the architect stat high sensitive troponin-i assay using worldwide data.The review shows that the median patient result for the complaint lot is within established limits and comparable with other lots in the field, confirming no systemic issue for the lot.The device history record was reviewed and did not identify any non-conformances or deviations.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for architect stat high sensitive troponin-i reagent lot 28052ud00 was identified.

• 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: 12800355
• MDR Text Key: 283393867
• Report Number: 3005094123-2021-00209
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 12/03/2021

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: 11/11/2021
• Device Catalogue Number: 03P25-27
• Device Lot Number: 28052UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 11/23/2021
• Supplement Dates FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR INTGR, 01L86-40, (B)(4); ARC I1000SR INTGR, 01L86-40, (B)(4)
• Patient Age: 95 YR
• Patient Sex: Male