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

Model Number MMT-397

Device Problem No Apparent Adverse Event (3189)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 06/24/2017

Event Type  Injury  

Manufacturer Narrative

We have evaluated the case based on the available data.Should new, relevant information become available, we will re-open the case and submit a follow-up mdr report.

Event Description

Unomedical ref number: (b)(4).A female diabetic patient is receiving insulin via a medtronic insulin pump equipped with two bayer contour next link wireless blood glucose sensors and a medtronic insulin infusion set, type quick-set paradigm, model mmt-397.She has over some months had problems with low and with high blood glucose values.She is contacting medtronic helpdesk with high blood glucose up to 600 mg/dl.This occurred after the previous day (the (b)(6) 2017) being discharged from southview hospital er where she was admitted due to hypoglycemia (28 mg/dl) and unconsciousness.She was in er for some 5 hours before the discharge to home.During the helpdesk communication it became clear that the patient had issues with correct use of the pump's keypad, with configuration of the sensors as well as with date/time configuration of the pump.The patient declined going through the pump's settings for basal rate and for bolus wizard settings.She was advised to have these settings checked/verified with her diabetes health care professional.During the infusion set troubleshoot no infusion set issues were identified.No data suggest causal relation between fluctuating blood glucose values and infusion set malfunction(s).No infusion set lot numbers were provided.No used infusion sets were available for investigations at unomedicals test facility.Note: patient also reported having been hospitalised (b)(6) hospital) for a few days due to hyperglycemia in early (b)(6) 2017.

• 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: 6986448
• MDR Text Key: 90520083
• Report Number: 3003442380-2017-00016
• 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: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• 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 Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2017
• 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): Hospitalization; Life Threatening