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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 80/9 PCC
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QUICK-SET® PARADIGM®; QUICK-SET 80/9 PCC Back to Search Results
Lot Number 5262909
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient had issues with the tubing three days ago from the day of this report ((b)(6) 2019), as the infusion set's tubing disconnected from the quick release at the site while sleeping.The patient woke up with high blood glucose level.The site location was at patient's upper buttock and the pump was located on top of the dress.The infusion had been in use for 2 days.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 the patient's body.Upon investigation performed on the returned used device (1 set), it was found that the tubing was detached from the tubing connector.No further information available.
 
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Brand Name
QUICK-SET® PARADIGM®
Common Device Name
QUICK-SET 80/9 PCC
MDR Report Key9294315
Report Number3003442380-2019-01918
Device Sequence Number13992583
Product Code FPA
UDI-Device Identifier05705244006577
UDI-Public05705244006577
Combination Product (Y/N)N
PMA/510(K) Number
K160648
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Expiration Date12/01/2021
Device Lot Number5262909
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/12/2019
Initial Report FDA Received Date11/08/2019
Patient Sequence Number1
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