MAUDE Adverse Event Report: SILHOUETTE PARADIGM; COMFORT SHORT 110/13 PCC

Model Number	MMT-382600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4).Event occurred in (b)(6).It was reported that the infusion set's tubing got disconnected while the patient was sleeping.The patient often rotates while sleeping.The site location was patient's abdomen and the pump was located on right side.Moreover, the infusion had been used for less than 24 hours.Reportedly, the infusions were stored in room temperature.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.
Event or Problem Description
On 12-oct-2020: follow up information was submitted to update health effect - clinical code and result of complaint investigation of the reference samples showed that all test results were within specifications.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 canada.It was reported that the infusion set's tubing got disconnected while the patient was sleeping.The patient often rotates while sleeping.The site location was patient's abdomen and the pump was located on right side.Moreover, the infusion had been used for less than 24 hours.Reportedly, the infusions were stored in room temperature.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.

• Brand Name: SILHOUETTE PARADIGM
• Common Device Name: COMFORT SHORT 110/13 PCC
• MDR Report Key: 10447357
• Report Number: 8021545-2020-00113
• Device Sequence Number: 14523882
• Product Code: FPA
• UDI-Device Identifier: 05705244009141
• UDI-Public: 05705244009141
• Combination Product (Y/N): N
• PMA/510(K) Number: K162812
• 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 Expiration Date: 10/01/2022
• Device Model Number: MMT-382600
• Device Lot Number: 5297683
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 10/12/2020
• Patient Sequence Number: 1