MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT STAT TROPONIN-I REAGENT KIT; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Model Number 2K41-27

Device Problem Low Test Results (2458)

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

Event Date 08/12/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6) (same patient 2 different samples) all available patient information is included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a false negative architect troponin-i result for a patient that was reported and questioned by the medical provider.The tech stated they released 2 samples that were collected at the same time, on (b)(6) 2022 at 11:58 am: (b)(6).The report was amended for (b)(6).The following data was provided (normal range: < 0.028 ng/ml): (b)(6) initial result: < 0.028 ng/ml: repeat: 0.037, 0.036, 0.050 ng/ml (plasma - lithium heparin, no gel).(b)(6) (poured off sample): initial result: 0.035 ng/ml, repeat: 0.033, 0.037 ng/ml source of poured off sample: initial result: 0.036 ng/ml, repeat: 0.042, 0.049 ng/ml (plasma - lithium heparin with gel).There was no impact to patient management reported.

Manufacturer Narrative

This follow up is being submitted to include the initial coding in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.

Manufacturer Narrative

The complaint investigation for a false negative architect stat troponin-i results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.A ticket search for lot 69918un22 did not identify an increased complaint activity related to the issue under review.A review of ticket trending data for the architect stat troponin-i was performed and no related trends were identified.A review of historical analysis for the lot 69918un22 which was evaluated using worldwide data from customers in the field.The patient median data (divided into 3 groups) and cal f rlu mean were analyzed and compared to an established control limit.This evaluation indicated that all three levels of the patient medians and the cal f rlu mean for the lot 69918un22 are within the established limits.Therefore, no unusual reagent lot performance was identified for the lot 69918un22.The historical performance of the reagent lot using worldwide data will be used in place of retained file sample analysis.Device history record review was performed on lot 69918un22, which did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for architect stat troponin-i reagent lot 69918un22 was identified.

• Brand Name: ARCHITECT STAT TROPONIN-I REAGENT KIT
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15304936
• MDR Text Key: 304029206
• Report Number: 1415939-2022-00067
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 00380740048525
• UDI-Public: 00380740048525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2022

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: 04/30/2023
• Device Model Number: 2K41-27
• Device Catalogue Number: 02K41-27
• Device Lot Number: 69918UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 09/06/2022; 10/06/2022
• Supplement Dates FDA Received: 09/28/2022; 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR MOD, 01L86-01, I1SR60271; ARC I1000SR MOD, 01L86-01, I1SR60271; ARC I1000SR MOD, 01L86-01, I1SR60271