MAUDE Adverse Event Report: INSET¿30; INSET 30 60/13 GREY

Lot Number	5076075
Medical Device Problem Code	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 the patient had cracked/broken tubing.The patient reported that during the night the tubing broke and separated from the needle.The blood glucose was greater than or equal to 250 mg/dl but less than 500 mg/dl.Upon investigation, it was found that the tubing was detached from the tubing connector (due to insufficient glue in the connection).No further information available.

• Brand Name: INSET¿30
• Common Device Name: INSET 30 60/13 GREY
• MDR Report Key: 8462874
• Report Number: 3003442380-2019-00786
• Device Sequence Number: 16465802
• Product Code: FPA
• UDI-Device Identifier: 05705244007109
• UDI-Public: 05705244007109
• Combination Product (Y/N): N
• PMA/510(K) Number: K061374
• 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: 02/01/2019
• Device Lot Number: 5076075
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2016
• Initial Report FDA Received Date: 03/28/2019
• Patient Sequence Number: 1