MAUDE Adverse Event Report: UNOMEDICAL A/S MIO; INSET INFUSION SET

Model Number MMT-975

Device Problem Bent (1059)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2017: the reference samples were visually inspected and tested for flow, leak and ventilation to pcc.All test results were within specifications.The batch record # (b)(4) was verified and found it within specifications.Based on the investigation and test results the claimed failure can not be confirmed.If new information becomes available the complaint will be re-opened and appropriate actions will be taken.

Event Description

Unomedical reference number: (b)(4).On (b)(6) 2017 a female diabetic patient experienced high blood glucose and bent cannula and the patient was hospitalized due to coma.Patient was admitted to bristol regional hospital.The blood glucose was greater than 900 mg/dl at time of hospitalization.Cause of hospitalization per hcp: coma.Patient was wearing pump at time of hospitalization.Patient was treated with manual injection.No further information available.

• Brand Name: MIO
• Type of Device: INSET INFUSION SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320 ; 548167000
• MDR Report Key: 6727366
• MDR Text Key: 80492333
• Report Number: 3003442380-2017-00009
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2017

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
• Device Operator: No Information
• Device Expiration Date: 02/01/2020
• Device Model Number: MMT-975
• Device Lot Number: 5178192
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/14/2017
• Initial Date FDA Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening