MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT STAT MYOGLOBIN REAGENT KIT; MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL

Catalog Number	02K43-25
Medical Device Problem Codes	Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Calibrate (2440); High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Abbott has identified architect stat myoglobin, list number 02k43-25, lot number 50808un23 did not meet the minimum microparticle concentration label claim of 0.10% solids due to a formulation issue.Customers observed quality control (qc), calibration, precision issues, and the microparticle inside the bottle appeared lighter in color.An internal study showed elevated imprecision for lot number 50808un23.Architect stat myoglobin, list number 02k43-20, lot number 60104un23 used the same microparticle concentrate as lot number 50808un23, however no performance issue was demonstrated.This lot was mixed properly but the material that was used for formulation was too concentrated.There is potential for delay in results as well as falsely depressed or falsely elevated results when using lot 50808un23, however there have been no reported delay of results or adverse impact to patient management as a result of this issue.There is no potential for delay of results or incorrect results when using lot 60104un23.
Additional Manufacturer Narrative
Additional information for section d4: d4- catalog number 02k43-20, d4- udi(unique identified): (b)(4) and d4- lot number 60104un23.The investigation into this issue found that during manufacturing, the microparticle concentrate used in reagent lots 50808un23 and 60104un23 was not properly mixed.As a result, an insufficient amount of microparticles was added to reagent lot 50808un23 and a higher percentage of microparticles was added to reagent lot number 60104un23.A product recall letter was issued on 21feb2024 to all customers who have received shipments of architect stat myoglobin reagent lot numbers 50808un23 and 60104un23.The product recall letter notifies the customer of the issue and the potential impact to patient results with use of lot 50808un23.The product recall letter instructs customers to discontinue use of and destroy any remaining inventory of lot 50808un23 and 60104un23 according to their laboratory procedures and immediately contact customer support to order a replacement product.

• Brand Name: ARCHITECT STAT MYOGLOBIN REAGENT KIT
• Common Device Name: MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18808682
• Report Number: 1415939-2024-00008
• Device Sequence Number: 7169003
• Product Code: DDR
• UDI-Device Identifier: 00380740003302
• UDI-Public: 00380740003302
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K042924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/29/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: 02K43-25
• Device Lot Number: 50808UN23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1415939-02/27/2024-001-R
• Patient Sequence Number: 1
• Patient Sex: Unknown