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 No Display/Image (1183); Failure of Device to Self-Test (2937)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 11/26/2020

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's daughter reported via phone call that customer experienced low and high blood glucose level.Customer's blood glucose value was 50 mg/dl at the time of the incident.Another blood glucose level was 370 and 250 mg/dl.The customer was assisted with troubleshooting for low blood glucose.Customer had been using insulin pump system within 48 hours of reported low blood glucose event.The customer was neither in the emergency room, nor admitted into hospital as a result of low blood glucose.Customer did not allege insulin pump was over delivering.Customer stated that they performed high pressure test and insulin pump failed it twice.Insulin pump was not working.The device will not be returned for analysis.Frn-unk-rsvr, unomed inf set.

• 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; * 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: 10933235
• MDR Text Key: 219107996
• Report Number: 2032227-2020-211586
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000190439
• UDI-Public: (01)000000763000190439
• 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: 12/01/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG3P7RA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/02/2020
• Date Device Manufactured: 08/21/2019
• 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
• Patient Age: 75 YR
• Patient Weight: 220