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

Model Number 2K41-27

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Low Test Results (2458)

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

Event Date 07/20/2022

Event Type  malfunction  

Event Description

During preparation of a conjugate bulk formulation, the third party manufacturer (tpm), fisher diagnostics, (b)(4), discovered that the previous conjugate bulk utilized in the architect stat troponin-i reagent kit, ln 2k41-27, lot number 63718un22 was manufactured with insufficient quantities of the heterophilic blocking agents.There is a potential for falsely elevated or falsely depressed patient results for a subset of patients who are human anti-mouse antibody (hama) or rheumatoid factor (rf) positive.There has been no reported adverse impact to patient management as a result of this issue.

Manufacturer Narrative

The investigation to-date from fisher diagnostics identified that the manufacturing process order instructions were not clear to manufacturing personnel.Appropriate corrective action(s) will be deployed for any additional contributions to causes subsequently identified in the ongoing investigation.Abbott is responsible for execution of this remedial action and a product recall letter was sent to all customers who received the impacted lot of architect stat troponin-i reagent, ln 2k41-27, lot 63718un22 informing them of the following actions: immediately discontinue use of architect stat troponin-i, list number 2k41-27 lot number 63718un22 and destroy all inventory of lot 63718un22 according to their laboratory procedures.Contact customer support to order replacement material.Review the product recall letter with their medical director or laboratory management and follow their laboratory protocol regarding the need for review of previously reported patient results using lot number 63718un22.

• 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: 15164859
• MDR Text Key: 303891037
• Report Number: 1415939-2022-00053
• 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: Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/04/2022

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: 06/30/2023
• Device Model Number: 2K41-27
• Device Catalogue Number: 02K41-27
• Device Lot Number: 63718UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1415939-07/30/22-002-R
• Patient Sequence Number: 1
• Treatment: ARCHITECT (B)(4), LIST NUMBER 01L86 AND 01L87; ARCHITECT (B)(4), LIST NUMBER 03M74