MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT INSULIN

Catalog Number 08K41-26

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient demographic information provided by the customer.

Event Description

The customer reported falsely elevated architect insulin results on one patient.The results provided were initial insulin result when in the er = 4200miu/ml.The insulin is being tested every 30 minutes and the last value provided was 16miu/ml.There was no reported impact to patient management.

Manufacturer Narrative

Suspect medical device lot # from 85020lp07 to 08020lp35 a review of tickets determined that there are no other complaints for lot 08020lp35 and there were no trends identified for the product for the issue.Return testing was not completed as returns were not available.Accuracy testing was performed with a retained kit of lot 08020lp35 and an internal insulin panel.All acceptance criteria were met, which indicates acceptable product performance.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on our investigation no product deficiency was identified for the architect insulin reagent, lot 08020lp35.

• Brand Name: ARCHITECT INSULIN
• Type of Device: INSULIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 9539783
• MDR Text Key: 221318651
• Report Number: 1415939-2020-00001
• Device Sequence Number: 1
• Product Code: CFP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2020
• Device Catalogue Number: 08K41-26
• Device Lot Number: 08020LP35
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER,; ARCHITECT I2000SR ANALYZER, LN 03M74-01,; LN 03M74-01, SERIAL # (B)(6); SERIAL # (B)(6)
• Patient Age: 55 YR