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

Catalog Number	02K43-20
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	01/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed that quality controls (qc) were out of range low after use of architect stat myoglobin reagent list 02k43-20, lot 60104un23.The customer provided following data for the qc.Low level: 48.9 ng/ml, 47.8 ng/ml with the range 60.2-83.0 ng/ml and high level was 257 ng/ml with the range 339-459 ng/ml.There was no reported impact to patient management.
Additional Manufacturer Narrative
The investigation into this issue found that during manufacturing, the microparticle concentrate used in reagent lot 60104un23 was not properly mixed.As a result, 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 number 60104un23.The product recall letter notifies the customer of the issue and the potential impact to patient results with use of lot 60104un23.The product recall letter instructs customers to discontinue use of and destroy any remaining inventory of lot 60104un23 according to their laboratory procedures and immediately contact customer support to order a replacement product.
Additional Manufacturer Narrative
Section h4 - device mfg date was updated from 06/06/2023 to 06/29/2023.
Event or Problem Description
The customer observed that quality controls (qc) were out of range low after use of architect stat myoglobin reagent list 02k43-20, lot 60104un23.The customer provided following data for the qc.Low level: 48.9 ng/ml, 47.8 ng/ml with the range 60.2-83.0 ng/ml and high level was 257 ng/ml with the range 339-459 ng/ml.There was no reported impact to patient management.

• 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: 18904133
• Report Number: 1415939-2024-00028
• Device Sequence Number: 7876679
• Product Code: DDR
• UDI-Device Identifier: 00380740003296
• UDI-Public: 00380740003296
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 03/14/2024

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: 02K43-20
• Device Lot Number: 60104UN23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• 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, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Sex: Unknown