MAUDE Adverse Event Report: UNOMEDICAL A/S SILHOUETTE PARADIGM; COMFORT SHORT

Model Number MMT-381

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Diabetic Ketoacidosis (2364); Lethargy (2560); Multiple Organ Failure (3261)

Event Date 12/10/2013

Event Type  Death  

Manufacturer Narrative

On (b)(6) 20: the reference samples were visually inspected and tested for needle, flow, leak and ventilation test.All test results were 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.

Event Description

(b)(4).In (b)(6) 2013 a male diabetic patient died due to diabetic ketoacidosis.Son was not feeling well and stayed home from school.He stayed in bed and the parents could hardly not wake him up.When he woke he was lethargic and the blood glucose levels was 800 mg/dl.Patients was admitted to the hospital but was moved to two different hospitals within a few hours to get better care.Over the next three days he continued to get worse and every organ were shutting down until he was legally brain dead.No infusion set malfunctions was described.

• Brand Name: SILHOUETTE PARADIGM
• Type of Device: COMFORT SHORT
• 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: 6943400
• MDR Text Key: 89072221
• Report Number: 8021545-2017-00006
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162812
• 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: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2018
• Device Model Number: MMT-381
• Device Lot Number: 5037926
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2013
• 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