MAUDE Adverse Event Report: QUICK-SET PARADIGM; QUICK-SET 46/6 PCC

Model Number	MMT-394
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).The patient's mother reported that her daughter's the infusion set that was inserted was completely disconnected from the clamp site of the tubing that connects to body.She mentioned that the tubing laid away from the pump - almost as if it only slipped off.Moreover, the insulin was messed all over and her daughters blood glucose level was very high.However, they managed to bring it down with injections.Further, it was stated that the tubing ends were not bent or broken off.No further information available.

• Brand Name: QUICK-SET PARADIGM
• Common Device Name: QUICK-SET 46/6 PCC
• MDR Report Key: 10565425
• Report Number: 3003442380-2020-00379
• Device Sequence Number: 11464043
• Product Code: FPA
• UDI-Device Identifier: 05705244006232
• UDI-Public: 05705244006232
• 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

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-394
• Device Lot Number: 5174485
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 09/22/2020
• Patient Sequence Number: 1