MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC MIO MMT-943 INSULIN INFUSION SET

Model Number MMT-943

Device Problem Bent (1059)

Patient Problems Fall (1848); Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

The available information indicates that patient over-corrected (over dosed) with the manual insulin injections thus going rapidly from hyperglycemia to hypoglycemia.

Event Description

Unomedical reference: (b)(4).This report concerns an (b)(6) citizen and the incident occurred in (b)(6).A male diabetic patient is receiving insulin via a medtronic pump and medtronic infusion set mio (mmt-943).On (b)(6) 2018 he experience hyperglycemia possibly due to bent soft cannula.He treats with manual insulin injections which cause him to become hypoglycemic.He collapses in the kitchen, falls to the floor creating an open head wound.Wife finds him on the floor.He is taken to (b)(6) by ambulance with blood glucose of 1.9 mmol/l and is treated with blood glucose stabilization and stitches.He was still wearing his insulin pump when admitted to hospital.Medtronic helpline recommends discussing incident with hcp verifying suitable insertion sites and to consider mio 30 (30 degree angled insertion instead of 90 degree) to minimise likelihood of future bend/kink of soft cannulas.

• Brand Name: MEDTRONIC MIO MMT-943 INSULIN INFUSION SET
• Type of Device: INSULIN 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
• MDR Report Key: 7262834
• MDR Text Key: 99769505
• Report Number: 3003442380-2018-00011
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244007499
• UDI-Public: 05705244007499
• 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: 02/12/2018

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: Lay User/Patient
• Device Expiration Date: 08/01/2020
• Device Model Number: MMT-943
• Device Lot Number: 5199696
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization