MAUDE Adverse Event Report: QUICK-SET PARADIGM; QUICK-SET 110/6 PCC

Model Number	MMT-398
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.On (b)(6) 2020, it was reported that when the patient woke up, the infusion set's tubing came out of the cap where connected to the site connector/ quick release portion while she was sleeping and her blood glucose level was 470mg/dl.The site location was patient's thigh and the pump was located next to her.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.The pump was not dropped with the set connected to patient's body.No further information available.
Event or Problem Description
On 21-dec-2020: follow up information was submitted to update awareness date and the result of complaint investigation of the returned used device (1 tubing) showed that the tubing was detached from the tubing connector.Based on the result: type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2020, it was reported that when the patient woke up, the infusion set's tubing came out of the cap where connected to the site connector/ quick release portion while she was sleeping and her blood glucose level was 470mg/dl.The site location was patient's thigh and the pump was located next to her.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.The pump was not dropped with the set connected to patient's body.No further information available.

• Brand Name: QUICK-SET PARADIGM
• Common Device Name: QUICK-SET 110/6 PCC
• MDR Report Key: 10668825
• Report Number: 3003442380-2020-00421
• Device Sequence Number: 2743674
• Product Code: FPA
• UDI-Device Identifier: 05705244006690
• UDI-Public: 05705244006690
• Combination Product (Y/N): Y
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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 Number: MMT-398
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 12/20/2020
• Patient Sequence Number: 1