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 Type  malfunction  

Manufacturer Narrative

There was no further patient information provided by the customer.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer reported false elevated insulin results for a (b)(6) year old female patient when processing on the architect i2000.The following data was provided: baseline 30 uu/ml.30 min 60 uu/ml.60 min 116 uu/ml 120 min 267 uu/ml the customer stated the results were not consistent with the patient's medical history and were questioned by the physician.Additional patient history provided was an (b)(6) value of 6.3%.The customer did not provide their reference range.No patient harm was reported.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined that there are no other complaints for lot 11020lp41 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 11020lp41 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 11020lp41.

• 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: 9953770
• MDR Text Key: 228604009
• Report Number: 1415939-2020-00033
• 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: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2020
• Device Catalogue Number: 08K41-26
• Device Lot Number: 11020LP41
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-01, SERIAL (B)(6); LN 03M74-01, SERIAL (B)(6)
• Patient Age: 70 YR