MAUDE Adverse Event Report: UNOMEDICAL A/S QUICK-SET PARADIGM; QUIKC-SET PCC

Model Number MMT-399

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hypoglycemia (1912)

Event Date 06/23/2013

Event Type  Death  

Event Description

Reporter alleges: (b)(6) died between (b)(6) 2013, as result of severe hypoglycemia events caused by the allegedly malfunction of the insulin pump and infusion sets he had been utilizing in (b)(6) 2013.On or about (b)(6) 2013, (b)(6) was utilizing the minimed insulin pump and medtronic quick-set sets in a reasonable and foreseeable manner in an effort to manage and control his diabetes.On or about the evening of (b)(6) 2013, (b)(6) witnessed no issues or complications with (b)(6) in the management of his type 1 diabetes.On or about the morning of (b)(6) 2013 (b)(6) was found non responsive in his bed by (b)(6).(b)(6) fire department emergency services was contacted and rushed to provide emergency health care on (b)64) 2013.(b)(6) was declared dead upon their arrival.The toxicology report in (b)(6) autopsy found that he had a blood glucose reading in his vitreous fluid lower than could be detected.Such readings are suggestive of severe hypoglycemia and over delivery of insulin.

Manufacturer Narrative

No relevant testing could be performed.Since the lot number was not available, the batch records and the complaint database could not be reviewed for relevant deviations and similar complaints.We have not been able to collect more information from our distributor.No lot number available.Hospital name unk.No information if the patient had any symptoms up to event.Death certificate not available due to hippa.Autopsy report not available due to hippa.Toxicology report not available due to hippa.No information if whether the used device will be returned for investigation.Unomedical hereby consider this case to be closed.

• Brand Name: QUICK-SET PARADIGM
• Type of Device: QUIKC-SET PCC
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3, osted; lejre 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3, osted; lejre 4320 ; 8167000
• MDR Report Key: 4898051
• MDR Text Key: 6072510
• Report Number: 3003442380-2015-00011
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 07/01/2015

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 07/01/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 42 YR
• Patient Weight: 83