MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 60/6 PCC

Lot Number	5208243
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hypoglycemia (1912)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).The patient reported that his father found him unconscious and admitted him in the emergency room in the hospital for low blood glucose level (2.1 mmol/l) and seizure.Reportedly, the patient received treatment through intravenous route and underwent electroencephalogram, ultrasounds (brain), bladder and kidney exam and various blood investigations.The patient was hospitalized for 3 weeks.Currently, the blood glucose was reported as 10 mmol/l.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 60/6 PCC
• MDR Report Key: 8342173
• Report Number: 3003442380-2019-00508
• Device Sequence Number: 19229426
• Product Code: FPA
• UDI-Device Identifier: 05705244006317
• UDI-Public: 05705244006317
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Operator of Device: No Information
• Device Expiration Date: 01/12/2021
• Device Lot Number: 5208243
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 02/15/2019
• Patient Sequence Number: 1