MAUDE Adverse Event Report: UNOMEDICAL A/S UNKNOWN, INFUSION SET

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

The claimed failure cannot be confirmed.No lot number nor no reference samples have been received/reported.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 diabetic male patient on pump therapy experienced an hyperglycemic event with blood glucose levels up to 1600 mg/dl that took the patient into a hospitalization.The patient was in a diabetic coma for 4 days.Patient stated that his ex wife came home and tried to wake him up and would not get up, patient was rushed to the hospital and treated to lower blood glucose levels, there was no malfunction or set failure that is confirmed that could have lead the patient into this life threatening event.No further information available.

• Brand Name: UNKNOWN, INFUSION SET
• Type of Device: UNKNOWN
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320 ; 0455816700
• MDR Report Key: 7240388
• MDR Text Key: 98965634
• Report Number: 3003442380-2018-00008
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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