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

Model Number MMT-864

Device Problems Low Test Results (2458); Insufficient Information (3190)

Patient Problems Hypoglycemia (1912); Convulsion, Clonic (2222); Loss of consciousness (2418)

Event Date 02/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Unomedical is still pending information about this event, therefore no testing has been performed at this time.A follow-up report will be sent no later than 02/09/2018.

Event Description

(b)(4).Incident occurred in (b)(6).On (b)(6) 2017 a male diabetic patient on pump therapy experienced a low blood glucose level event during the evening, which resulted in a hypoglycemic event and the patient experienced convulsions and lost consciousness.Patient was admitted to hospital (b)(6) in (b)(6).Patients mother mentioned that her son had been hospitalized for twenty days due to hypoglycemia.No further information provided at this time.

Manufacturer Narrative

02/05/2018.Incident happened in (b)(6).The reference samples were visually inspected and tested for flow and leak and ventilation.All test results were within specifications.The batch record # 5158839 was verified and found it within specifications.Based on the investigation and test results the claimed failure can not be confirmed.If new information becomes available the complaint will be re-opened and appropriate actions will be taken.

Event Description

(b)(4).Incident occurred in (b)(6).On (b)(6) 2017 a male diabetic patient on pump therapy experienced a low blood glucose level event during the evening, which resulted in a hypoglycemic event and the patient experienced convulsions and lost consciousness.Patient was admitted to hospital (b)(6).Patients mother mentioned that her son had been hospitalized for twenty days due to hypoglycemia.No further information provided.

• 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
• MDR Report Key: 7199030
• MDR Text Key: 97492429
• Report Number: 3003442380-2018-00005
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244005778
• UDI-Public: 05705244005778
• Combination Product (y/n): N
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2021
• Device Model Number: MMT-864
• Device Lot Number: 5158839
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening