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

Model Number MMT-397

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hyperglycemia (1905)

Event Date 11/18/2019

Event Type  Death  

Manufacturer Narrative

Lot 5154294.Reference samples have been analysed without any findings of malfunctions.A batch review has been conducted: all within specifications.

Event Description

Unomedical reference (b)(4) (medtronic ref svn (b)(4)).On 25-nov-2019 medtronic informs unomedical about a legal, fatal case.A (b)(6) year old female diabetic patient is treated with insulin via a medtronic insulin pump and a quick-set insulin infusion set, model mmt-397, manufactured by unomedical.A lawyer alleges that she died on (b)(6) 2019 following an overdose of insulin caused by infusion set vent block membrane failure.The overdose allegedly led to severe hypoglycemia which was not treated and thus ultimately led to the death of the patient.Note: the fatal incident occurred some 2 months after medtronic and unomedical launched a voluntary recall of the potentially affected infusion set products on 11-sep-2017.Recall references are unomedical: ma-2017-02; medtronic: fa-784.At the moment we do not have further facts on the fatal incident.Due to the scarce information available unomedical cannot presently make any reasonable assessment of possible causal relation between the fatal incident and the used infusion set.

• Brand Name: MEDTRONIC QUICK-SET PARADIGM INFUSION SET
• 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: 9478955
• MDR Text Key: 171562541
• Report Number: 3003442380-2019-00008
• 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: K106648
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2019
• Device Model Number: MMT-397
• Device Lot Number: 5154294
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/17/2019
• 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: 54 YR