MAUDE Adverse Event Report: T:90¿ INFUSION SET; INSET II 60/6 GREY

Lot Number	5137910
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4).Event occurred in the united states.The patient reported that the infusion set tubing came unglued from the connector piece that clipped into the site while she was sleeping last night.The blood glucose level at the time of event was 140 mg/dl and she did not notice any damage when the package was first opened.No further information available.

• Brand Name: T:90¿ INFUSION SET
• Common Device Name: INSET II 60/6 GREY
• MDR Report Key: 8472173
• Report Number: 3003442380-2019-00715
• Device Sequence Number: 1920508
• Product Code: FPA
• UDI-Device Identifier: 05705244004412
• UDI-Public: 05705244004412
• Combination Product (Y/N): N
• PMA/510(K) Number: K032854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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 Lot Number: 5137910
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 04/02/2019
• Patient Sequence Number: 1