MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 80/9 PCC

Lot Number	5250014
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4).Event occurred in the united states.The patient reported that at night, he experienced high blood glucose level up to 400 mg/dl.Subsequently, he received a blocked alarm for no insulin delivery when he looked at his set and noticed that the quick release had come loose as it was not locked in place.At 9:24 p.M., blood glucose level was at 180 mg/dl and at 11:29 p.M.It was 248 mg/dl.Furthermore, the infusion set's tubing detached at the quick release.He calculated the correction off the pump and gave himself a manual injection of 7 units while holding the infusion set in place, which seemed to have worked.At 11:37 p.M., blood glucose level was at 247 mg/dl after bolus.He did not think too much about it and had a big dinner.The site location was on the left side of patient's abdomen and the pump was located on the left side.Reportedly, the infusions were stored in the bedroom closet.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.No further information available.
Event or Problem Description
On 05-nov-2019: follow up information was submitted because result of complaint investigation of the returned used device (1 inserted set) showed that the visual test results were in accordance with specifications.Based on the result: device, method, result and conclusion codes were updated.Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that at night, he experienced high blood glucose level up to 400 mg/dl.Subsequently, he received a blocked alarm for no insulin delivery and when he looked at his set, he noticed that the quick release had come loose, as it was not locked in place.At 9:24 p.M., blood glucose level was 180 mg/dl and at 11:29 p.M.It was 248 mg/dl.Furthermore, the infusion set's tubing detached at the quick release.He calculated the correction off the pump and gave himself a manual injection of 7 units while holding the infusion set in place, which seemed to have worked.At 11:37 p.M., blood glucose level was at 247 mg/dl after bolus.He did not think too much about it and had a big dinner.The site location was on the left side of patient's abdomen and the pump was located on the left side.Reportedly, the infusions were stored in the bedroom closet.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 80/9 PCC
• MDR Report Key: 8924156
• Report Number: 3003442380-2019-01730
• Device Sequence Number: 19340091
• Product Code: FPA
• UDI-Device Identifier: 05705244006577
• UDI-Public: 05705244006577
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 10/01/2021
• Device Lot Number: 5250014
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 11/05/2019
• Patient Sequence Number: 1