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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK-SET PARADIGM UNO QUICK-SET 60/9 SC1 MECA

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QUICK-SET PARADIGM UNO QUICK-SET 60/9 SC1 MECA Back to Search Results
Model Number MMT-397A
Device Problem Material Deformation (2976)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states. It was reported that the patient experienced a bent tubing issue which led to blood glucose level of 349 mg/dl. On (b)(6) 2021, the patient was admitted to the hospital with blood glucose level of 600 mg/dl and diabetic ketoacidosis. During hospitalization, the patient was administered intravenous insulin infusion. The patient was hospitalized for two days. Currently, the patient's blood glucose level was 600 mg/dl. No further information available.
 
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Brand NameQUICK-SET PARADIGM
Type of DeviceUNO QUICK-SET 60/9 SC1 MECA
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key11588020
MDR Text Key242904161
Report Number3003442380-2021-00194
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
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-397A
Device Lot Number5321849
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2021
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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