MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715K

Device Problems Excess Flow or Over-Infusion (1311); Patient Device Interaction Problem (4001)

Patient Problems Fatigue (1849); Hypoglycemia (1912); Weakness (2145); Sweating (2444); Shaking/Tremors (2515)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.

Event Description

The customer reported via phone call that they experienced low blood glucose. Blood glucose reading was 43 mg/dl and 193 mg/dl. Customer stated insulin pump alleging possible over delivery because retainer ring damaged. Customer experienced symptom such as shaking, sweating, weakness, fatigue. Customer treated with food and chocolate. Customer was using insulin pump system within 48 hours of reported low blood glucose event. Customer was neither in emergency room nor admitted into hospital. Customer stated reservoir retainer ring had crack and able to lock in place. The insulin pump will be and reservoir will not be returned for analysis.

Manufacturer Narrative

Device passed the self test, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and delivery accuracy test at 0. 08690 inches. No discolored retainer noted. Device received with cracked retainer. (b)(4).

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 10447797
• MDR Text Key: 204182079
• Report Number: 2032227-2020-167995
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/25/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 10/14/2018
• Device MODEL Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device LOT Number: HG2G1RW
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/02/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 04/12/2018
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient TREATMENT DATA

Date Received: 08/25/2020 Patient Sequence Number: 1

Treatment

UNOMED INF SET