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

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier whole sid (b)(6).An evaluation is in process.

Event Description

The customer observed falsely elevated insulin patient results generated using the architect insulin reagents.The following data was provided (uu/ml).Sid (b)(6) result 72.80.Previous results for the patient were provided, 27.4, 34.7.Dilution linearity testing results ranged from 21.60 to 28.80.The patient is an (b)(6) weighing less than (b)(6).The mother of the (b)(6) is a diabetic patient.No impact to patient management was reported.

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, a review of field data, a review of labeling, and accuracy testing.No adverse trend was identified for the customer's issue.Review of field data found the complaint lot performance was comparable to other lots, and no issue was found.Labeling was reviewed and found to be adequate.Device history review did not identify any issues that may have caused the customer issue.The product was not available for return.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.Based on all available information and abbott diagnostics complaint investigation, the assay performed as intended and no product deficiency was identified.

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred, the device did not perform as intended.However, no systematic issue or product deficiency was identified.

• Brand Name: ARCHITECT INSULIN
• Type of Device: INSULIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 5869475
• MDR Text Key: 51938007
• Report Number: 1415939-2016-00082
• Device Sequence Number: 1
• Product Code: CFP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2016
• Device Catalogue Number: 08K41-26
• Device Lot Number: 61020LP77
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9 DA