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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
Model Number MMT-386
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Hyperglycemia (1905)
Type of Reportable Event Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states it was reported that, on (b)(6) 2019, the patient's infusion set's tubing became separated from the quick-set connector, close to the site location as the glue came undone from the o ring, while sleeping.This issue occurred for the 4th time, every sixth month or so.Reportedly, she woke up with blood glucose level of 389 mg/dl and diabetic ketoacidosis due to this issue.Further, the site location was at her right upper buttock and the pump was in the bed.The infusion had been used for the second day.Moreover, 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.No further information available.
 
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Brand Name
QUICK-SET® PARADIGM®
Common Device Name
QUICK-SET 80/9 PCC
MDR Report Key9640446
Report Number3003442380-2020-00134
Device Sequence Number2500282
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 Model NumberMMT-386
Device Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/08/2019
Initial Report FDA Received Date01/29/2020
Patient Sequence Number1
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