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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK-SET® PARADIGM® QUICK-SET 60/6 PCC

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QUICK-SET® PARADIGM® QUICK-SET 60/6 PCC Back to Search Results
Lot Number UNKNOWN
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
(b)(4). Event occurred in the united states. The patient's nurse stated that some tubing did not work, and she had a lot trouble while connecting. The patient experienced high blood glucose and fell. The patient was hospitalized 5 days prior to this report possibly due to generalized weakness, suspected diabetic ketoacidosis and high blood glucose level, which was reported to be around 500 mg/dl. At the time of this report, the patient was still in hospital. No further information available.
 
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Brand NameQUICK-SET® PARADIGM®
Type of DeviceQUICK-SET 60/6 PCC
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key8360757
MDR Text Key136845854
Report Number3003442380-2019-00261
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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