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

Catalog Number 02K42-28

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.

Event Description

The customer reported falsely elevated architect stat ck-mb results for two patients.The first patient (sample id (b)(6)) generated a ck-mb result of 32.0 ng/ml.A new sample ((b)(6)) drawn 3 hours later generated a ck-mb of 2.0 ng/ml.The second patient (sample id (b)(6)) generated a ck-mb result of 17.9 ng/ml and retest (sid (b)(6)) 2.3 ng/ml.A second sample drawn 3 hours later (sid (b)(6)) generated a ck-mb result of 2.2 ng/ml and retest (sid (b)(6)) 2.3 ng/ml.No specific patient information was provided and no adverse impact to patient management was reported.

Manufacturer Narrative

Further investigation of the issue included a review of the complaint text, a search for similar complaints, review of instrument logs, in-house testing and a review of labeling.Review of complaint activity determined that there is normal complaint activity for likely cause lot 79350un17.Tracking and trending report review for the architect stat ck-mb assay determined that there are no related adverse or non-statistical trends.In addition, a device history record review was performed on lot 79350un17, which did not identify any issues.The customer's instrument logs were reviewed for the samples tested in january 2018.This review did not identify conclusive information to indicate an instrument or sample integrity issue occurred.An internal ck-mb panel was tested with retained kits of the likely cause reagent lot.Acceptance criteria were met, which indicates acceptable product performance.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information, no systemic issue or deficiency of the architect stat ck-mb assay was identified.

Manufacturer Narrative

Section reason why the device was not evaluated was changed.

• 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
• MDR Report Key: 7203536
• MDR Text Key: 98074001
• Report Number: 1415939-2018-00004
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 02K42-28
• Device Lot Number: 79350UN17
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/02/2018
• Initial Date FDA Received: 01/18/2018
• Supplement Dates Manufacturer Received: 01/18/2018; 02/07/2018
• Supplement Dates FDA Received: 01/19/2018; 02/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR; ARCHITECT I1000SR; ARCHITECT I1000SR; LIST 01L86-97, SERIAL (B)(4).; LIST 01L86-97, SERIAL (B)(4).; LIST 01L86-97, SERIAL B)(4).