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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S QUICK-SET® PARADIGM®

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UNOMEDICAL A/S QUICK-SET® PARADIGM® Back to Search Results
Model Number MMT-397
Device Problem Leak/Splash (1354)
Patient Problem Coma (2417)
Event Date 12/19/2019
Event Type  Injury  
Manufacturer Narrative
The complaint has been reviewed based on the customer complaint description and evaluates that no further investigation can be performed before information about lot number and/or used samples are received for testing.
 
Event Description
Unomedical reference number: (b)(4). This event occured in (b)(6). A diabetic patient on pump therapy reported that the patient was hospitalized on (b)(6)2020 with high blood glucose and symptoms of nausea, vomiting, abdominal pain and breath difficulties. The patient experienced being in coma. Blood glucose at time of event was 1200 mg/dl. The patient was wearing pump at time of event. The infusion set was reported wet and leaking. No further information available.
 
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Brand NameQUICK-SET® PARADIGM®
Type of DeviceQUICK-SET
Manufacturer (Section D)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer (Section G)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key9691708
MDR Text Key182714972
Report Number3003442380-2020-00001
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2020
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
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/11/2020 Patient Sequence Number: 1
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