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 08/24/2022

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the samples that were tested were hama or rf positive, therefore this incident is conservatively being reported as related to rcr 1415939-07/30/22-002-r.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 in receipt of the impacted lot of architect stat troponin-i reagent, ln 2l41-27, lot 38718un22 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.(b)(6).All available patient information was included.No additional information was provided.

Event Description

The customer observed falsely depressed architect stat troponin-i results generated on an architect i1000sr analyzer for multiple patients.The customer¿s reference range is 0-0.038 ng/ml.The following sample ids and results were provided: (b)(6) initial result = 0.01 ng/ml, repeat result = 2.927 ng/ml.(b)(6) initial result = 0.018 ng/ml, repeat result = 0.021 ng/ml.(b)(6) initial result = 0.016 ng/ml, repeat result = 0.028 ng/ml.(b)(6) initial result = 0.018 ng/ml, repeat result = 0.026 ng/ml.(b)(6) initial result = 0.01 ng/ml, repeat result = 0.132 ng/ml.(b)(6) initial result = 0.035 ng/ml, repeat result = 0.024 ng/ml.(b)(6) initial result = 0.01 ng/ml, repeat result = 0.594 ng/ml.(b)(6) initial result = 0.01 ng/ml, repeat result = 0.127 ng/ml.(b)(6) initial result = 0.01 ng/ml, repeat result = 0.01 ng/ml.(b)(6) initial result = 0.021 ng/ml, repeat result = 0.031 ng/ml.(b)(6) initial result = 0.05 ng/ml, repeat result = 0.668 ng/ml.(b)(6) initial result = 0.447 ng/ml, repeat result = 0.142 ng/ml.(b)(6) initial result = 0.022 ng/ml, repeat result = 0.01 ng/ml.(b)(6) initial result = 0.029 ng/ml, repeat result = 0.01 ng/ml.(b)(6) initial result = 0.01 ng/ml, repeat result = 0.015 ng/ml.(b)(6) initial result = 0.01 ng/ml, repeat result = 2.927 ng/ml.(b)(6) initial result = 0.01 ng/ml, repeat result = 0.132 ng/ml.(b)(6) initial result = 0.01 ng/ml, repeat result = 0.594 ng/ml.(b)(6) initial result = 0.01 ng/ml, repeat result = 0.127 ng/ml.(b)(6) initial result = 0.01 ng/ml, repeat result = 0.01 ng/ml.(b)(6) initial result = 0.05 ng/ml, repeat result = 0.668 ng/ml.It is unknown whether the patients are hama or rf positive.No impact to patient management was reported.

• 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: 15360894
• MDR Text Key: 301268884
• Report Number: 1415939-2022-00070
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/06/2022

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: 08/23/2022
• Initial Date FDA Received: 09/06/2022
• 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: ARC I1000SR INTGR, 01L86-40, I1SR61536.