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

Model Number MMT-397

Device Problem Insufficient Information (3190)

Patient Problems Hypoglycemia (1912); Overdose (1988)

Event Date 12/24/2017

Event Type  Injury  

Manufacturer Narrative

A wrong (too concentrated) insulin type was used by the patient.There are no data suggesting any failures with regards to the insulin pump, insulin reservoir or the insulin infusion set.Due to the wrong type of insulin, the patient had consistently received five time too much active insulin compared the intended insulin dosing.

Event Description

Unomedical reference: (b)(4).A male diabetic patient is receiving insulin via a medtronic insulin pump and a medtronic quick-set infusion set (mmt-397).Patient reports multiple episodes of hypoglycemic events.One such episode, (b)(6) 2017, resulted in ambulance and er care at a hospital.Patient feels that his pump is delivering too much insulin and has begun to sleep with pump fully disconnected.After lengthy trouble-shooting the patient informs that he is using humulin r u500 insulin.Medtronic help desk explains that he must use the u100 humulin type with his pump.Patient is asked to contact his hcp for prescriptions of the correct humulin r u100 insulin.Per volume, u500 contains five times as much active insulin compared to the u100 type.I.E.: the patient has been 500% overdosed due to using the wrong insulin type.This fact fully explains the multiple experienced hypoglycemic incidents.(medtronic reference is (b)(4)).

• Brand Name: MEDTRONIC QUICK-SET PARADIGM INSULIN INFUSION SET
• Type of Device: INSULIN INFUSION SET FOR PUMP THERAPY
• 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: 7265897
• MDR Text Key: 99883286
• Report Number: 3003442380-2018-00012
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• 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 - STATED LOT IS WRONG
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization