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 Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hyperglycemia (1905); Blood Loss (2597)

Event Date 01/10/2020

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.(b)(4).

Event Description

The customer reported via phone call that the customer experienced hyperglycemia.The customer blood glucose level was 438 mg/dl at the time of incident and the current blood glucose level was 135 mg/dl.The customer was assisted with troubleshooting.The customer was treated with changed the infusion set and gave himself more bolus for high blood glucose.Customer was using insulin pump system within 48 hours of reported high blood glucose event.Customer reports they did not contact their health care professional regarding the high blood glucose.Customer stated that they did not alleging insulin pump was under delivering.Customer stated that when customer removed the infusion set, blood squirted out, then after a while, the site developed bruising the size of softball.Customer reported bleeding stopped.Customer reported that they did not receive medical treatment as a result of the site issue.Customer did receive a calibration not accepted alert.Customer did receive a change sensor alert.The insulin pump will not be returned for analysis.

• 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: 9595328
• MDR Text Key: 175208160
• Report Number: 3004209178-2020-56529
• 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: Other
• Type of Report: Initial
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FRN-MMT-332-RSVR, UNOMED SET, OZP-MMT-7020-SNSR
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Weight: 228