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

Lot Number	5177983
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
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that the infusion set's tubing had detached from the infusion site.The fork shaped plastic connector piece remained connected to the infusion site.Patient's blood glucose level at the time of this event was 296 mg/dl, which was treated with insulin delivery via injection.As a result of over correcting, patient's blood glucose level dropped down to 56 mg/dl.The patient ate corn flakes to correct it.The patient 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: 8462896
• Report Number: 3003442380-2019-00725
• Device Sequence Number: 1341042
• 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 Expiration Date: 02/01/2020
• Device Lot Number: 5177983
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 03/28/2019
• Patient Sequence Number: 1