MAUDE Adverse Event Report: QUICK-SET PARADIGM; QUICK-SET 80/9 PCC

Model Number	MMT-386
Medical Device Problem Codes	Connection Problem (2900); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that patient had inserted the infusion set in the morning and during the night the catheter came loose at the site of the quick release, but not the quick release itself.Further, this resulted in high blood glucose level of 28 mmol/l, in the morning of (b)(6) 2020.Moreover, on (b)(6) 2020, at 16:32:59 hours (at the moment of this report), his blood glucose level was reduced to 05 mmol/l.No further information available.
Event or Problem Description
On 04-feb-2021: follow up information was submitted to update health effect impact code and visual inspection was performed on the returned used device (1 set), and it was found that the click-legs had defects making it impossible to use the infusion set it does not make the click, (the click-legs of tubing connector are deformed).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 netherlands.It was reported that patient had inserted the infusion set in the morning and during the night the catheter came loose at the site of the quick release, but not the quick release itself.Further, this resulted in high blood glucose level of 28 mmol/l, in the morning of (b)(6) 2020.Moreover, on (b)(6) 2020, at 16:32:59 hours (at the moment of this report), his blood glucose level was reduced to 05 mmol/l.No further information available.

• Brand Name: QUICK-SET PARADIGM
• Common Device Name: QUICK-SET 80/9 PCC
• MDR Report Key: 10046230
• Report Number: 3003442380-2020-00265
• Device Sequence Number: 19558221
• Product Code: FPA
• UDI-Device Identifier: 05705244006577
• UDI-Public: 05705244006577
• Combination Product (Y/N): N
• 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: 05/01/2022
• Device Model Number: MMT-386
• Device Lot Number: 5269544
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 02/04/2021
• Patient Sequence Number: 1