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

Model Number MMT-923

Device Problem Insufficient Information (3190)

Patient Problem Coma (2417)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016, a visual inspection and tests for flow, leak and ventilation to the pcc reservoir connector were performed on the returned unused devices (8 sets).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.Clinical evaluation: the patient reported feeling nauseous in the morning (5 am) with glycemia at 4 g/l.Patient changed the infusion set and gave a bolus to bring down blood glucose level.Patient was not able to bring down blood glucose level by bolus and called doctors and firemen.Patient was hospitalized and experienced going into diabetic coma.There is no information regarding possible pump malfunction, infusion set malfunction or user error causing this event.No information if patient received any pump alarm due to interrupted flow of insulin causing blood glucose level to rise available.No used infusion set is returned for testing.No clinical consequences reported due to this event.Unomedical a/s was unable to obtain patient's contact information from our distributor, due to regional privacy laws.By submission of this report we now consider this case as closed.

Event Description

(b)(4).Event happened in (b)(6).Complainant reports that she was nauseous in the morning (5 am) with glycemia at 4 g/l.She changed her catheter and injected a bolus.Glycemia was still high.At 12h00 am, she called doctors and firemen, glycemia was at 5 g/l.Patient was hospitalized in emergency and was in coma with ketones, due to unexplained high blood glucose level.

• Brand Name: MIO
• Type of Device: INSET LL
• 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: 6321550
• MDR Text Key: 67099170
• Report Number: 3003442380-2017-00004
• 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: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Model Number: MMT-923
• Device Lot Number: 5157424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Date Manufacturer Received: 01/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening