MAUDE Adverse Event Report: UNOMEDICAL A/S QUICK-SET PARADIGM; INSULIN INFUSION SET

Model Number MMT-397

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Encephalopathy (1833); Hypoglycemia (1912)

Event Date 01/16/2016

Event Type  Death  

Manufacturer Narrative

We do not expect to receive further information on this fatal incident.However, should we receive new, relevant information we will re-open and update this case and provide fda with a follow-up mdr.

Event Description

(b)(4).The patient's husband and a legal representative informed medtronic helpline and reported that the patient experienced a hypoglycemic episode with blood glucose (bg) lower than 20 mg/dl.Patient was found unconscious at home, husband removed insulin pump and observed a low reservoir and a no-delivery alarm on pump display.Patient was hospitalised via ems on (b)(6) 2016 at the (b)(6) hospital.Here patient suffered complications such as hypoxic and anoxic episodes and eventually ischemic encephalopathy.Patient remained on life-support until (b)(6) 2016 and passed away on (b)(6) 2016 while in the hospital.

• Brand Name: QUICK-SET PARADIGM
• Type of Device: INSULIN 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: 7047915
• MDR Text Key: 92588387
• Report Number: 3003442380-2017-00019
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006416
• UDI-Public: 05705244006416
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160648
• 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: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-397
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2017
• 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; Hospitalization