MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT INSULIN

Model Number 8K41-27

Device Problem High Test Results (2457)

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

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter email address was too long.The entire email address is (b)(6).An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account generated false elevated architect insulin of 358 and 376 pmol/l on a non-diabetic patient ((b)(6) year old european, gender not provided).Two additional samples from the patient generated architect insulin of 120 and 75 pmol/l.The 3 patient samples were processed on another architect analyzer with values of 371.7, 92, 71 pmol/l.The account uses a normal insulin range of 17.8 to 173 pmol/l.The patient history was (b)(6) since 1991 with triple therapy treatment and has normal tpsa and glycemia results.No impact to patient management was reported.

Manufacturer Narrative

The complaint evaluation was performed which included a search for similar complaints, and the review of complaint text, trending data, labeling, device history records, retained file kit testing of reagent lot 13121lp44.In house testing of panels which mimic patient samples was completed using retained file kit of the complaint lot 13121lp44.All specifications were met indicating that the lot is performing acceptably.Labeling was reviewed and found to adequately address falsely elevated results.A ticket search for lot 13121lp44 did not identify an increase in complaint activity related to the falsely elevated results.A review of ticket trending data for the architect insulin was performed with no adverse trends identified.Device history record review was performed on lot 13121lp44, which did not show any potential non-conformances, deviations, or nonconformances.Based on the investigation no systemic issue or deficiency of the architect insulin for lot number 13121lp44 was identified.

• 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: 10281037
• MDR Text Key: 219530318
• Report Number: 1415939-2020-00092
• Device Sequence Number: 1
• Product Code: CFP
• UDI-Device Identifier: 00380740017569
• UDI-Public: 00380740017569
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2020
• Device Model Number: 8K41-27
• Device Catalogue Number: 08K41-27
• Device Lot Number: 13121LP44
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR LIST 03M74-97; ARCHITECT I2000SR LIST 03M74-97; SERIAL (B)(6) ; SERIAL (B)(6)
• Patient Age: 65 YR