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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 5208243
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Hypoglycemia (1912)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4). Event occurred in (b)(6). The patient reported that his father found him unconscious and admitted him in the emergency room in the hospital for low blood glucose level (2. 1 mmol/l) and seizure. Reportedly, the patient received treatment through intravenous route and underwent electroencephalogram, ultrasounds (brain), bladder and kidney exam and various blood investigations. The patient was hospitalized for 3 weeks. Currently, the blood glucose was reported as 10 mmol/l. 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 Key8342173
MDR Text Key136232976
Report Number3003442380-2019-00508
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 Received02/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/12/2021
Device Lot Number5208243
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2018
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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