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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 Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states. On (b)(6) 2021, it was reported that the infusion set's tubing was not staying inserted as the plastic show heat lines and glue was pulled out. It pulled off from the body at the site location while the patient was sleeping, and the patient experienced high blood glucose level which they tried to treat it with manual injection. The site location was patient's leg, and the pump was located at the side. Moreover, the infusion had been used for one day. Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity. There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body. Currently, the patient's blood glucose level was 121 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 Key12317418
MDR Text Key266390775
Report Number3003442380-2021-00371
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,Followup
Report Date 10/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-397A
Device Lot Number5342467
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2021
Was Device Evaluated by Manufacturer? Yes
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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