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

Model Number MMT-1715KR

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); Weakness (2145)

Event Date 09/15/2020

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

Customer reported via phone call that they experienced low blood glucose.The customer blood glucose level was 50 mg/dl at the time of incident and other blood glucose values were 113 mg/dl, 192 mg/dl, 301 mg/dl, 211 mg/dl, 198 mg/dl, 173 mg/dl, 158 mg/dl and 136 mg/dl.Customer reported that they alleged insulin pump was over delivering.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, nor was emergency medical service dispatched as a result of low blood glucose.Customer treated with food.The customer experienced symptoms such as legs and arms were weak.The customer was assisted with troubleshooting and declined for low blood glucose.The insulin pump and reservoir will not be returned for analysis.¿.

• Brand Name: 630G INSULIN PUMP MMT-1715KR 630G
• 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; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 8185464805
• MDR Report Key: 10578953
• MDR Text Key: 208287439
• Report Number: 2032227-2020-181701
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000173036
• UDI-Public: (01)000000763000173036
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KR
• Device Catalogue Number: MMT-1715KR
• Device Lot Number: HG34CMV
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2020
• Date Device Manufactured: 01/22/2019
• 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: UNOMED SET
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 62