MAUDE Adverse Event Report: ABBOTT LABORATORIES IRON REAGENT KIT; PHOTOMETRIC METHOD, IRON (NON-HEME)

Catalog Number 08P3920

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

Event Date 09/18/2023

Event Type  Injury  

Event Description

Abbott alinity iron reagents are running 20% higher for patient results.Abbott is refusing to correct these and has stated that all current lots are affected.20% is a very large amount and will be noticeable on patient results.

• Brand Name: IRON REAGENT KIT
• Type of Device: PHOTOMETRIC METHOD, IRON (NON-HEME)
• Manufacturer (Section D): ABBOTT LABORATORIES
• MDR Report Key: 17788521
• MDR Text Key: 324063170
• Report Number: MW5145989
• Device Sequence Number: 1
• Product Code: JIY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08P3920
• Device Lot Number: 21118Y600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention