MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT INSULIN

Catalog Number 08K41-27

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated architect insulin assay results for 3 patients.The customer provided the following data.The retest results were generated at another laboratory, test method/ platform is unknown): sample 1: initial 27 retest 14; sample 2: initial 30 retest 17; sample 3 initial 38 retest 9.There was no adverse impact to patient management reported.

Manufacturer Narrative

On (b)(6) 2016 the suspect medical device lot number was updated.This is documented.Further investigation of the customer issue included a review of the complaint text, in-house testing, a search for similar complaints, a batch record review and a review of labeling.Return material was not available from the customer.An accuracy testing protocol was executed; testing met the acceptance criteria and determined the reagent is performing acceptably.Tracking and trending did not identify an adverse trend for the lot in question.No issues were identified which would indicate a product deficiency from the batch record review.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency and no malfunction of the architect insulin reagent, list (b)(4), lot 60121lp76, was identified.

Manufacturer Narrative

Correction to the evaluation summary previously documented.The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the documentation of no malfunction is inaccurate.However, no systemic 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: 5736198
• MDR Text Key: 47794959
• Report Number: 1415939-2016-00068
• Device Sequence Number: 1
• Product Code: CFP
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2016
• Device Catalogue Number: 08K41-27
• Device Lot Number: 60151LP76
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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