MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 80/6 PCC

Model Number	MMT-387
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
(b)(4).Event occurred in the united states.The patient reported that the infusion set's tubing detached while she was sleeping.In the morning of (b)(6) 2019, the patient woke up with blood glucose level at 265 mg/dl.This issue occurred with two infusion sets.The site location was patient's left arm and the pump was located on the belt area.The infusion had been in use for two days.Reportedly, the infusions were used as normal.There was stress or pull on the tubing while she was sleeping and the pump was not dropped with the set connected to the patient's body.At the time of this report, the patient was stable.No further information available.
Event or Problem Description
On 06-feb-2020: follow up information was submitted for expiration date and lot number.Also, the result of complaint investigation of the returned used device (1 set) showed that the tubing was detached from the tubing connector.Based on the result: method, result and conclusion codes were updated.Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that the infusion set's tubing detached while she was sleeping.In the morning of (b)(6) 2019, the patient woke up with blood glucose level at 265 mg/dl.This issue occurred with two infusion sets.The site location was patient's left arm and the pump was located on the belt area.The infusion had been in use for two days.Reportedly, the infusions were used as normal.There was stress or pull on the tubing while she was sleeping and the pump was not dropped with the set connected to the patient's body.At the time of this report, the patient was stable.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 80/6 PCC
• MDR Report Key: 8868663
• Report Number: 3003442380-2019-01685
• Device Sequence Number: 16967767
• Product Code: FPA
• UDI-Device Identifier: 05705244006492
• UDI-Public: 05705244006492
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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 Expiration Date: 01/01/2022
• Device Model Number: MMT-387
• Device Lot Number: 5253002
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 02/06/2020
• Patient Sequence Number: 1