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

Model Number MMT-923

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hypoglycemia (1912); Coma (2417)

Event Date 07/14/2017

Event Type  Injury  

Manufacturer Narrative

The reference samples were visually inspected and tested for flow, leak and ventilation to the pcc.All test results were within specifications.The batch record 5170778 was verified and found it within specifications.The claimed failure cannot be confirmed.An investigation has been performed based on the customer complaint description and the reference samples from the same lot number.According to unomedical's traceability records, no relevant deviations were found.If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.

Event Description

(b)(4).In (b)(6) 2017 a female diabetic patients experienced coma due to low blood glucose levels.A few hours after an infusion set change, the patient´s blood glucose level fell to about 35 mg/dl.911 was called and patient was hospitalized.Patient is claiming that the cause of the event might be related to the recall fa784.Patient is not claiming any infusion set malfunctions.

• 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: 6943401
• MDR Text Key: 89262115
• Report Number: 3003442380-2017-00012
• 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: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2019
• Device Model Number: MMT-923
• Device Lot Number: 5170778
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• 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