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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Coma (2417)

Event Date 01/14/2018

Event Type  Death  

Manufacturer Narrative

Case information does not indicate causal relation between death and any possible infusion set failure.No further information is expected to become available.

Event Description

Unomedical reference: (b)(4).A daughter reports that her mother died.Mother went into coma with blood glucose at 800 mg/dl and was admitted to hospital on (b)(6) 2018 and died there on (b)(6) 2018.Daughter believes causes of death are coma as well as pre-existing heart failure.No further information is expected to become available.

• Brand Name: UNKNOWN
• Type of Device: INSULIN PUMP INFUSION SET
• 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
• MDR Report Key: 7618704
• MDR Text Key: 111640089
• Report Number: 3003442380-2018-00025
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2018
• 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): Death