MAUDE Adverse Event Report: SILHOUETTE PARADIGM; UNO COMFORT SHORT 46/13 SC1 MINI

Model Number MMT-368A

Device Problems Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Unomedical reference number: (b)(4).Event occurred in the united states.On (b)(6) 2022, it was reported that the patient's infusion set's tubing got detached at the site location after using the inserter at home and this issue occurred upon insertion.The site location was left side of patient's abdomen and the pump was located on the opposite side in relation to the site.Reportedly, the infusions were stored in the box.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, the patient's blood glucose level was 221 mg/dl.No further information available.

Event Description

On 19-may-2022: follow up information was submitted to update the awareness date.Moreover, the result of complaint investigation of returned used devices (two cannulas), showed that the visual test result was within specifications.Based on the result: medical device problem code, component code, 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 10-mar-2022, it was reported that the patient's infusion set's tubing got detached at the site location after using the inserter at home and this issue occurred upon insertion.The site location was left side of patient's abdomen and the pump was located on the opposite side in relation to the site.Reportedly, the infusions were stored in the box.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, the patient's blood glucose level was 221 mg/dl.No further information available.

• Brand Name: SILHOUETTE PARADIGM
• Type of Device: UNO COMFORT SHORT 46/13 SC1 MINI
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 13897434
• MDR Text Key: 288022140
• Report Number: 8021545-2022-00122
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244019492
• UDI-Public: 05705244019492
• Combination Product (y/n): Y
• PMA/PMN Number: K162812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MMT-368A
• Device Lot Number: 5362797
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Patient Sequence Number: 1