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

Model Number MMT-943

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Coma (2417)

Event Date 06/18/2017

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 5177291 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.Since patients mother had doubts about which of two lot numbers patient was using at the time of the event, two similar mdrs have been created: 3003442380-2017-00013 and 3003442380-2017-0014.

Event Description

Unomedical reference number (b)(4).In (b)(6) 2017 a female diabetic patient experienced low blood glucose levels and she tried to treat with juice.The patient was found two days later in coma with her pump disconnected from her body.By that time her blood sugar was 1600 mg/dl and her body temperature was 89, ph 6.9.Her kidneys had shut down and the fluid depressed her heart function.She also suffered deep tissue wounds due to being down for so long.She was in a coma for 18 days, intubated and on dialysis.She remained in intensive care for nearly a month before spending a month at a neuro rehab facility.Patient was not claiming any 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: 6978950
• MDR Text Key: 90287195
• Report Number: 3003442380-2017-00014
• 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: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2020
• Device Model Number: MMT-943
• Device Lot Number: 5177291
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2017
• 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; Life Threatening
• Patient Age: 20 YR