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

Catalog Number	02K42-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CK-MB
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 8515431
• Report Number: 1415939-2019-00024
• Device Sequence Number: 16647992
• Product Code: JHX
• UDI-Device Identifier: 00380740003258
• UDI-Public: 00380740003258
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K041596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 02K42-25
• Device Lot Number: 89206UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1