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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hypoglycemia (1912)

Event Date 10/13/2013

Event Type  Death  

Manufacturer Narrative

On 04/03/2019; no relevant testing could be performed.If lot information was available, the batch records and the complaint database would have been reviewed for relevant deviations and similar complaints.  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 the lot number is provided to investigate a potential origin of the product failure in the devices manufacturing traceability documents.

Event Description

(b)(4).The below event has been reported to unomedical as a legal case.On the (b)(6) 2013 a male diabetic patient experienced severe hypoglycemia caused by the malfunction of the insulin pump, insulin reservoirs and insulin infusion sets he had been utilizing, resulting in cognitive impairment, a motor vehicle accident, subsequent injuries and hospitalization, and eventually death.No further information provided.

• 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 (Section G): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8589573
• MDR Text Key: 144387234
• Report Number: 3003442380-2019-00004
• 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: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2019
• 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): Death