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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 Detachment of Device or Device Component (2907)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  malfunction  
Event Description
Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient's infusion set's tubing detached at the quick release, as it got detached from the adhesive of the site while doing normal activity.Her blood glucose level was over 500 mg/dl.This issue occurred with four infusion sets and it happened for three days till the patient was sent to the hospital on (b)(6) 2022 with blood glucose level of 600 mg/dl.The site location was the patient's abdomen, and the pump was on the same side.The infusion set had been used for less than one day.Further, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Moreover, there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.She was admitted in the hospital for two days.Currently, the patient's blood glucose level was 242 mg/dl.No further information available.
 
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Brand Name
QUICK SET PARADIGM
Type of Device
UNO QUICK-SET 60/9 SC1 MECA
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key15162062
MDR Text Key304838555
Report Number3003442380-2022-00918
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244017573
UDI-Public05705244017573
Combination Product (y/n)Y
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 08/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Expiration Date04/01/2024
Device Model NumberMMT-397A
Device Lot Number5352707
Initial Date Manufacturer Received 07/20/2022
Initial Date FDA Received08/04/2022
Patient Sequence Number1
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