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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Diarrhea (1811); Hyperglycemia (1905); Vomiting (2144); Heart Failure (2206); Respiratory Failure (2484)

Event Date 07/12/2017

Event Type  Death  

Manufacturer Narrative

On (b)(6) 2017 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

Unomedical reference number (b)(4).In (b)(6) 2017 a male diabetic patient died.It was reported that he experienced an elevated blood glucose level and later went into diabetic ketoacidosis (b)(6) 2016.The infusion set needle had become undone but did not know and when he checked and saw it was out.The customer died on (b)(6) 2017.The cause of the death was brain anoxia and brought on by a heart attack, respiratory failure the heart attack gave vomiting and diarrhea and had high blood glucose levels.The customer was not wearing the insulin pump at the time of death.He was off the insulin pump greater than 48 hours.

• 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 ; 458167000
• MDR Report Key: 7107624
• MDR Text Key: 94482095
• Report Number: 3003442380-2017-00025
• 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: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening