MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT STAT CK-MB

Catalog Number 02K42-25

Device Problem High Test Results (2457)

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

Event Date 03/23/2019

Event Type  malfunction  

Manufacturer Narrative

Complete information for section a patient information, 1.Patient identifier- multiple = pt#1 and sid08702797c an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer.

Event Description

The customer reported falsely elevated architect ck-mb results on two patients.The results provided were: pt#1 on (b)(6) 2019 = 59.9ng/ml / retest = 1.6ng/ml (normal range 0-4ng/ml); on (b)(6) 2019 sid08702797c = 54 / 2.7.There was no reported impact to patient management.

Manufacturer Narrative

A review of ticket trending and a lot search did not identify an increase in complaint activity related to falsely elevated results.Return testing was not completed as returns were not available.Accuracy testing was performed with a retained kit of lot 89206un18 and an internal ck-mb 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 the investigation no product deficiency was identified for the architect stat ck-mb, lot 89206un18.

• Brand Name: ARCHITECT STAT CK-MB
• Type of Device: CK-MB
• 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: 8515431
• MDR Text Key: 150422196
• Report Number: 1415939-2019-00024
• Device Sequence Number: 1
• Product Code: JHX
• UDI-Device Identifier: 00380740003258
• UDI-Public: 00380740003258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 02K42-25
• Device Lot Number: 89206UN18
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1