MAUDE Adverse Event Report: UNOMEDICAL A/S SURE-T PARADIGM; CONTACT DETACH PCC

Model Number MMT-864

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 05/19/2017

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.  the claimed failure cannot be confirmed.The complaint has been reviewed based on the customer complaint description and evaluates that no further investigation can be performed before either used samples are received for testing or that the lot number is provided to investigate a potential origin of the product failure in the devices manufacturing traceability documents.

Event Description

Unomedical reference number (b)(4).This event took place in (b)(6).In (b)(6) 2017 a female diabetic patient in (b)(6) died, patients father called medtronic minimed if the patients death might have been related to the medtronic minimed recall (b)(4).Coroner is investigating the death.No further information provided at this time.

• Brand Name: SURE-T PARADIGM
• Type of Device: CONTACT DETACH PCC
• 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 ; 548167000
• MDR Report Key: 7177841
• MDR Text Key: 96812828
• Report Number: 3003442380-2018-00003
• Device Sequence Number: 1
• Product Code: FPA
• 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: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-864
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2016
• 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
• Patient Age: 27 YR