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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Itching Sensation (1943); Rash (2033); Skin Irritation (2076)

Event Date 11/12/2018

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

The customer reported via phone call that they had a high blood glucose value of 568 mg/dl at the time of incident.Customer¿s other blood glucose level was 80 mg/dl to 140 mg/dl.The customer did not provide details regarding symptoms of their high blood glucose episodes.The customer was treated with bolus and manual injection.Customer stated that the skin irritation and rash.Customer was declined to troubleshoot.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: 8098770
• MDR Text Key: 128182672
• Report Number: 2032227-2018-65061
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00763000090197
• UDI-Public: (01)00763000090197(17)210411
• 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: 11/22/2018

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 Expiration Date: 04/11/2021
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG2G1RR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 11/22/2018
• Was Device Evaluated by Manufacturer?: No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR