MAUDE Adverse Event Report: INSET¿II; INSET II 60/9 BLUE

Lot Number	5147698
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 (b)(6).It was reported that in the original package, the tube had disengaged from the cannula, before the catheter was used.Reportedly, the blood glucose level was lesser than 250 mg/dl.Upon investigation, it was found that the glue was missing from the tubing connector (glue was misplaced on the tubing connector).No further information available.

• Brand Name: INSET¿II
• Common Device Name: INSET II 60/9 BLUE
• MDR Report Key: 8513174
• Report Number: 3003442380-2019-01127
• Device Sequence Number: 1899678
• Product Code: FPA
• UDI-Device Identifier: 05705244007451
• UDI-Public: 05705244007451
• 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: 05/15/2019
• Device Lot Number: 5147698
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 04/15/2019
• Patient Sequence Number: 1