MAUDE Adverse Event Report: CONTACT¿DETACH; CONTACT DETACH G29 60/6

Lot Number	UNKNOWN
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient's daughter reported an occlusion issue as patient was taken to the hospital.Patient was admitted to hospital with blood glucose level of 878 mg/dl and diagnosed with diabetes ketoacidosis.Patient had symptoms of lethargy, incoherency and vomiting.The patient received insulin via injection, fluids via intravenous route as corrective treatment and the insertion site was changed.The patient was hospitalized for more than three days.Currently, the patient was in the intensive care unit and was being treated with an insulin drip.No further information available.

• Brand Name: CONTACT¿DETACH
• Common Device Name: CONTACT DETACH G29 60/6
• MDR Report Key: 8535340
• Report Number: 3003442380-2019-01141
• Device Sequence Number: 10852877
• Product Code: FPA
• UDI-Device Identifier: 05705244005716
• UDI-Public: 05705244005716
• Combination Product (Y/N): N
• PMA/510(K) Number: K041545
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2016
• Initial Report FDA Received Date: 04/22/2019
• Patient Sequence Number: 1