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

Model Number MMT-394

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 09/18/2017

Event Type  Death  

Manufacturer Narrative

The reference samples were visually inspected and tested for flow, ventilation to the pcap and leak.All test results were within specifications.All 3 reported lot numbers were verified and found it within specifications: the batch record 5154164 was verified and found it within specifications; the batch record 5164700 was verified and found it within specifications; the batch record 5174485 was verified and found it within specifications.The claimed failure cannot be confirmed.An investigation has been performed based on the customer complaint description and the reference samples from the same lot number.According to unomedical's traceability records, no relevant deviations were found.If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.

Event Description

Unomedical reference number: (b)(4) reported diabetic patient from (b)(6) passed away on (b)(6) 2017.Coroner is investigating to see if the patients death is linked to the faulty batches of infusions sets.3 different lot numbers have been reported for this incident: 5154164, 5164700 and 5174485.We do not know which of the lot numbers have been in use at time of incident.No further information available.

• Brand Name: QUICK SET PARADIGM
• 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; aaholmevej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320 ; 548167000
• MDR Report Key: 7107631
• MDR Text Key: 94481898
• Report Number: 3003442380-2017-00023
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006232
• UDI-Public: 05705244006232
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-394
• Device Lot Number: UNKNOWN (SEE B5)
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 12/12/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death