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

Model Number MMT-399

Device Problem No Apparent Adverse Event (3189)

Patient Problems Stroke/CVA (1770); Death (1802); Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Coma (2417)

Event Date 08/04/2013

Event Type  Death  

Manufacturer Narrative

No relevant testing could be performed.If lot information was available, the batch records and the complaint database were reviewed for relevant deviations and similar complaints.This case has been closed due to missing information.No relevant testing could be performed.Since the lot number is unknown, no batch record review or testing of retained samples could be performed.If the lot number becomes available, the case will be re-opened and appropriate actions will be taken.Clinical evaluation: it is reported that patient was admitted to hospital the (b)(6) 2013, with hyperglycemia (no readings available) and acute cva (cerebrovascular accident).It is reported that patient was admitted for several days getting treated with iv insulin.Treatment and outcome for cva is not reported.Patient was found in diabetic coma on (b)(6) 2013 and was admitted to hospital.It is not reported for how long patient was home between the two hospitalizations.Patient required endotracheal intubation for mechanical ventilation.On (b)(6) 2013 she was discharged to a skilled nursing facility for treatment.Patient was eventually placed in hospice care and died in (b)(6) 2014.

Event Description

(b)(4).On (b)(6) 2013 a diabetic patient was hospitalized with hyperglycemia (no glucose readings available) and acute cerebrovascular accident (cva).It is reported that patient was admitted for several days getting treated with iv insulin.Treatment and outcome for cva is not reported.On (b)(6) 2013 the patient experienced diabetes ketoacidosis and was found in diabetic coma and was hospitalized.It is not reported for how long patient was home between the two hospitalizations.The patient required endotracheal intubation for mechanical ventilation.On (b)(6) 2013 she was discharged to a skilled nursing facility for treatment.The patient was eventually placed in hospice care and died in (b)(6) 2014.No further information available.This event was reported by legal representative via medtronic minimed.

• Brand Name: QUICK SET PARADIGM
• Type of Device: QUICK SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320 ; 548167000
• MDR Report Key: 5219373
• MDR Text Key: 30965951
• Report Number: 3003442380-2015-00021
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011071
• 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: 11/09/2015

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 Model Number: MMT-399
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/12/2015
• 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; Hospitalization