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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT CREATINE KINASE

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ABBOTT MANUFACTURING INC ARCHITECT CREATINE KINASE Back to Search Results
Model Number 7D63-21
Device Problem Low Test Results (2458)
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. There is no further patient information provided due to privacy issues.
 
Event Description
The customer reported falsely depressed creatine kinase (ck) on one patient generated on the architect analyzer. The results provided were: auto dilution 1:10
=
477. 4iu/l / manual dilution 1:10
=
32619. 1iu/l. There was no reported impact to patient management.
 
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Brand NameARCHITECT CREATINE KINASE
Type of DeviceCREATINE KINASE
Manufacturer (Section D)
ABBOTT MANUFACTURING INC
1921 hurd drive
irving TX 75038
Manufacturer (Section G)
ABBOTT MANUFACTURING INC
1921 hurd drive
irving TX 75038
Manufacturer Contact
christian lee
100 abbott park road
dept 09b9, bldg cp01-3
abbott park, IL 60064-3537
224668-294
MDR Report Key9446774
MDR Text Key219840123
Report Number1628664-2019-00751
Device Sequence Number1
Product Code CGS
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K983070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/02/2020
Device Model Number7D63-21
Device Catalogue Number07D63-21
Device Lot Number07560UN19
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2019
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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