MAUDE Adverse Event Report: AUTOSOFT 90¿; INSET II 60/6 GREY

Lot Number	5191551
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 the united states.The patient reported that infusion set tubing disconnected from the site and the tubing pulled out from the connector lead and this issue occurred with two infusion sets.Patient's blood glucose level was above 300 mg/dl at the time of both the incidents.The patient did not notice any damage when the package was first opened.No further information available.

• Brand Name: AUTOSOFT 90¿
• Common Device Name: INSET II 60/6 GREY
• MDR Report Key: 8526626
• Report Number: 3003442380-2019-01279
• Device Sequence Number: 16626473
• Product Code: FPA
• UDI-Device Identifier: 05705244014992
• UDI-Public: 05705244014992
• 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: 06/01/2020
• Device Lot Number: 5191551
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/18/2019
• Patient Sequence Number: 1