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

Model Number	MMT-387
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
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 the united states.On (b)(6) 2021, the patient reported that when she woke up, she noticed that the pump was not attached to her and when she went back to the bed she found that her infusion set's tubing broke in half at the middle of the tubing.This issue occurred while the patient was sleeping.Further, the site location was her stomach and the pump was located next to her.Moreover, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Further, there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Currently, her blood glucose level was 210 mg/dl.No further information available.
Event or Problem Description
On 23-jul-2021: follow up information was submitted to update awareness date and the result of complaint investigation of the returned used device (1 set) showed that the tubing had damages (it was completely cut).Based on the result: medical device problem 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 (b)(6) 2021, the patient reported that when she woke up, she noticed that the pump was not attached to her and when she went back to the bed she found that her infusion set's tubing broke in half at the middle of the tubing.This issue occurred while the patient was sleeping.Further, the site location was her stomach and the pump was located next to her.Moreover, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Further, there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Currently, her blood glucose level was 210 mg/dl.No further information available.

• Brand Name: QUICK-SET PARADIGM
• Common Device Name: UNO QUICK-SET 80/6 PCC MECA
• MDR Report Key: 11899829
• Report Number: 3003442380-2021-00262
• Device Sequence Number: 4404173
• Product Code: FPA
• UDI-Device Identifier: 05705244006492
• UDI-Public: 05705244006492
• 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 Expiration Date: 06/01/2023
• Device Model Number: MMT-387
• Device Lot Number: 5321826
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 07/23/2021
• Patient Sequence Number: 1