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U.S. Department of Health and Human Services

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

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ABBOTT LABORATORIES ARCHITECT STAT CK-MB Back to Search Results
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.
 
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Brand NameARCHITECT STAT CK-MB
Type of DeviceCK-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 Key8515431
MDR Text Key150422196
Report Number1415939-2019-00024
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041596
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue Number02K42-25
Device Lot Number89206UN18
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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