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

Model Number MMT-399

Device Problem No Apparent Adverse Event (3189)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 07/29/2017

Event Type  Injury  

Manufacturer Narrative

The claimed failure cannot be confirmed.An investigation has been performed based on the customer complaint description.No used samples returned for investigation nor any lot number provided.No relevant testing could be performed.If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.

Event Description

(b)(4).This incident occured in (b)(6).On (b)(6) 2017 a diabetic male patient on pump therapy experienced low blood glucose.He drove to a party (no alcohol, no drugs consumption) and passed out.After he came to himself, he called his brother (rescue assistant) who arrived soon after and called the ambulance.The patient was admitted to hospital ((b)(6)).Blood glucose at time of incident is unknown.Patient was discharged from hospital on (b)(6) 2017.Patient suffered blow-out fracture.The father of the patient reported the incident and assumed that the event was caused by the quick set infusion set.He excluded the possibility that there was moisture between the reservoir and the p-cap.No further information available.

• Brand Name: QUICK-SET PARADIGM INFUSION SET
• Type of Device: QUICK-SET PARADIGM
• 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 ; 4548167000
• MDR Report Key: 7107773
• MDR Text Key: 94494433
• Report Number: 3003442380-2017-00026
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006331
• UDI-Public: 05705244006331
• 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: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• 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
• Date Manufacturer Received: 11/21/2017
• 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): Hospitalization; Life Threatening