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

Model Number MMT-397

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 10/06/2017

Event Type  Death  

Manufacturer Narrative

The lot mentioned is affected by the medtronic global recall fa-784 which was announced/launched on 11-sep-2017 (i.E.4 weeks earlier than the reported fatal accident).We do try to obtain further information on this fatal incident.Should we receive new, relevant information we will re-open and update this case and provide fda with a follow-up mdr.

Event Description

Unomedical reference (b)(4).Patients daughter reported that her father passed away at home.According to daughter the cause of death was diabetes due to over-delivery by the recalled infusion sets.The daughter stated that her father had no illnesses that may have led to his passing.The fathers blood glucose was unknown at the time of death.The father was not wearing the insulin pump at the time of death.The pump had been disconnected by more than 2 days prior to passing by the health care professional due to low blood glucose levels.The father was not using sensors.The daughter believes that the recalled infusion sets led to the fathers a1c dropping to 6.5 and then passing away.The daughter stated that her father received 92 units but did not clarify if this was basal or bolus insulin.The daughter declined to return the insulin pump and infusion set for analysis.

• 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: 7074559
• MDR Text Key: 93450042
• Report Number: 3003442380-2017-00021
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2019
• Device Model Number: MMT-397
• Device Lot Number: 5165458
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2017
• 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
• Patient Age: 71 YR