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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included, no additional patient information was available.During the investigation into this issue found that during manufacturing, the microparticle concentrate used in reagent lot number 50808un23 was not properly mixed.As a result, an insufficient amount of microparticles was added to reagent lot 50808un23.A product recall letter was issued on 21feb2024 to all customers who have received shipments of architect stat myoglobin reagent lot numbers 50808un23.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 according to their laboratory procedures and immediately contact customer support to order a replacement product.
Event or Problem Description
The customer observed that microparticles in the microparticles bottle appeared lighter than usual, low rlu during calibration and bio rad quality control were out of range low and patient comparison was high while using architect stat myoglobin reagent list (b)(4), lot 50808un23.The following results were provided for sample comparison between 2 reagent lot numbers for myoglobin.50808un23 37319un23 bias sid1: 36.3, 26.6 , -26.72%.Sid2: 117.7, 65.3, -44.52%.Sid3: 256.9, 154.1, -40.02%.Sid4: 364.8, 206.3, -43.45%.Sid5: 810.6, 552, -31.9%.Comparison was completed using patient samples for comparison only and not for the patient management.There was no impact to patient management reported.

• 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: 18886330
• Report Number: 1415939-2024-00014
• Device Sequence Number: 7539629
• Product Code: DDR
• UDI-Device Identifier: 00380740003302
• UDI-Public: 00380740003302
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/12/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, (B)(4).
• Patient Sex: Unknown