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

Model Number MMT-394

Device Problem Kinked (1339)

Patient Problems Death (1802); Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 07/12/2017

Event Type  Death  

Manufacturer Narrative

This is an initial report concerning a hospitalized patient who died within 48 hours.Hospital treatment is unknown.Official cause of death is unknown.We believe this occurred in (b)(6), and that the reporting mother is (b)(6) years old and the now deceased son was in his mid-fifties.We are trying to obtain further information from the distributor ((b)(4)).We hope to submit a follow-up mdr within a month's time.No set has been returned.

Event Description

Unomedical reference number is: (b)(4).A mother calls medtronic help desk to ask that future supplies to her son are cancelled.Suspectedly due to a bent cannula the son got blood glucose levels at over 600 mg/dl and was submitted to hospital with a diagnosis of diabetic ketoacidosis.Insulin pump was removed at hospital.Some 48 hours after submission (on (b)(6) 2017) the patient passed away.According to mother, the cause of death was 'diabetes' and not any other health conditions.Unomedical is actively seeking further information, such as e.G.Hospital treatment, official cause of death, on this complaint case.

Manufacturer Narrative

This is an initial report concerning a hospitalized patient who died within 48 hours.Hospital treatment is unknown.Official cause of death is unknown.We believe this occurred in (b)(6), and that the reporting mother is (b)(6) and the now deceased son was in his mid-fifties.We are trying to obtain further information from the distributor (medtronic).We hope to submit a follow-up mdr within a month's time.Update per 30-aug-2017: our distributor (b)(4) has nor been able to obtain any further information.We therefore close the case - should new relevant information emerge, we will submit an updated follow-up report to fda.

Event Description

(b)(4).Initial report text: a mother calls medtronic helpdesk to ask that future supplies to her son are cancelled.Suspectedly due to a bent cannula the son got blood glucose levels at over 600 mg/dl and was submitted to hospital with a diagnosis of diabetic ketoacidosis.Insulin pump was removed at hospital.Some 48 hours after submission (on (b)(6) 2017) the patient passed away.According to mother, the cause of death was 'diabetes' and not any other health conditions.Unomedical is actively seeking further information, such as e.G.Hospital treatment, official cause of death, on this complaint case.Update per 30-aug-2017: it has not been possible for distributor ((b)(4) to obtain any further information.We believe that the reporting mother is an elderly lady and that her son (the deceased patient) was in the mid-fifties when he died.

• Brand Name: QUICK-SET PARADIGM INSULIN INFUSION SET
• Type of Device: QUICK-SET PARADIGM INSULIN INFUSION SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, DK-43 20; DA DK-4320
• Manufacturer (Section G): UNOMEDICAL; aaholmvej 1-3; osted; lejre, DK-43 20; DA DK-4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, DK-43-20 ; 548167000
• MDR Report Key: 6759470
• MDR Text Key: 81560032
• Report Number: 3003442380-2017-00010
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006232
• UDI-Public: 05705244006232
• 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,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-394
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2017
• Was Device Evaluated by Manufacturer?: No
• 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