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

Model Number MNT-397

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 08/04/2014

Event Type  Death  

Event Description

(b)(4).Date medtronic were legal aware: (b)(4) 2015.(b)(6).Is pt death alleged: yes.Event description: it is alleged by (b)(6) lawyer that the following occured: "(b)(5) ((b)(6)) had type 1 diabetes.He was using a medtronic 530g pump: serial number pbr (b)(4) with continuous glucose monitor.The cgm threshold suspend alarm was set to 70 mg/dl, and the low glucose alert was set to 80 mg/dl.On (b)(6) 2014, he went to his bedroom, telling his roommates he was not feeling well.One of his roommates found him dead a few hours later.The autopsy report has not been received yet, but the death certificate states he died of complications of diabetes mellitus.

Manufacturer Narrative

No relevant testing could be performed.If lot information becomes available, the batch records and the complaint database will be reviewed for relevant deviations and similar complaints.A copy of the death certificate and information regarding the pt's pump history up to the incident have been requested.A request for lot number of device and getting the used device back for investigation have been submitted.A follow up will be submitted no later than (b)(4) 2015.

Manufacturer Narrative

We have not been able to collect more information from our distributor.A copy of the death certificate is not available.There are no pump history for this patient.No lot number available.The used device will not be returned for investigation.An initial mdr report was submitted june 2, 2015.(b)(4) hereby consider this case to be closed.

• Brand Name: QUICK-SET PARADIGM
• Type of Device: QUICK-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: 4820575
• MDR Text Key: 16631118
• Report Number: 3003442380-2015-00008
• 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,distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MNT-397
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 06/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates 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: 41 YR
• Patient Weight: 63