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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK-SET® PARADIGM® UNO QUICK-SET 60/9 PCC MECA

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QUICK-SET® PARADIGM® UNO QUICK-SET 60/9 PCC MECA Back to Search Results
Model Number MMT-397
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states. On (b)(6) 2009, the patient's mother reported that her son was admitted in the hospital at 4:00 am, due to pancreatitis and diabetic ketoacidosis. Reportedly, he tried changing his set last night prior to going to hospital but his blood glucose level did not go down with pump, so he gave injections, and it came down a little. At the time of hospitalization, his blood glucose level was reported as 545 mg/dl. Currently, he is admitted in the intensive care unit and is administered insulin drip. Moreover, his mother stated that it did leak out near p-cap on quickset. No further information available.
 
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Brand NameQUICK-SET® PARADIGM®
Type of DeviceUNO QUICK-SET 60/9 PCC MECA
MDR Report Key12604693
MDR Text Key275927851
Report Number3003442380-2021-00567
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 10/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-397
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2021
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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