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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hypoglycemia (1912); Brain Injury (2219)

Event Date 12/17/2017

Event Type  Injury  

Manufacturer Narrative

No relevant testing could be performed.If lot information was available, the batch records and the complaint database were reviewed for relevant deviations and similar complaints.  the claimed failure cannot be confirmed.The complaint has been reviewed based on the customer complaint description and evaluates that no further investigation can be performed before either used samples are received for testing or that the lot number is provided to investigate a potential origin of the product failure in the devices manufacturing traceability documents.

Event Description

(b)(4).On (b)(6) 2017 a male diabetic patient on pump therapy experienced a low blood glucose level event.Patient's blood glucose level decreased to 20 mg/dl and patient went in a hypoglycemic coma and suffered brain seizures.It is unknown how long he was in this state prior to being found.Wife is unaware of what actually caused his bg to drop but believes that at 4am he went to bed and usually takes off the pump but that evening he did not.Patient was admitted to the hospital they were trying to give him glucose to keep his blood sugar up but they couldn't it would just continue to drop and then on tuesday (b)(6) 2017 bg started to rise and they made the bg go up to 300 and then would bring it down slowly.A week later patient died of natural causes.No further information provided.

• Brand Name: INFUSION SET UNKNOWN
• Type of Device: INFUSION SET UNKNOWN
• 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: 7233578
• MDR Text Key: 98757214
• Report Number: 3003442380-2018-00007
• 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: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• 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: 01/11/2018
• 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): Life Threatening