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 False Reading From Device Non-Compliance (1228)

Patient Problem Hypoglycemia (1912)

Event Date 07/06/2017

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.

Event Description

The customer reported via phone call that they had inaccurate sensor readings.The customer's blood glucose during the incident was 26 mg/dl while the sensor was reading at 64 mg/dl.The customer treated with food.Customer stated the insulin pump shows he is in suspend on low but sensor is not connected.Customer performed troubleshooting for sensor issues but declined troubleshooting for low blood glucose.The insulin pump will not be returned for analysis.

Manufacturer Narrative

Additional information has been received which was not included with the initial medwatch report.The additional information has been provided with this report.

Event Description

The customer reported via phone call that they had inaccurate sensor readings.The customer's sensor glucose values were 26, 59, 177, 58, 64 and 122 mg/dl while the blood glucose values were 59, 82, 236, 37, 26, 61 and 177 mg/dl.The customer treated with food.Customer stated the insulin pump shows he is in suspend on low but sensor was not connected.Customer performed troubleshooting for sensor issues but declined troubleshooting for low blood glucose.The insulin pump will not be returned for analysis.The sensor will be returned for analysis.

Manufacturer Narrative

Additional information has been received which was not included with the initial medwatch report.The additional information has been provided with this report.Follow up one was not submitted.The information has been provided with this report.

Event Description

The customer reported via phone call that they had inaccurate sensor readings.The customer's sensor glucose values were 26, 59, 177, 58, 64 and 122 mg/dl while the blood glucose values were 59, 82, 236, 37, 26, 61 and 177 mg/dl.The customer treated with food.Customer stated the insulin pump shows he is in suspend on low but sensor was not connected.Customer performed troubleshooting for sensor issues but declined troubleshooting for low blood glucose.The insulin pump will not be returned for analysis.The sensor will 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
• MDR Report Key: 7265086
• MDR Text Key: 99858716
• Report Number: 3004209178-2018-50213
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840
• 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: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2018

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 Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG1QS0F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 07/06/2017; 07/06/2017
• Supplement Dates FDA Received: 03/27/2018; 03/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2017
• 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: 61 YR
• Patient Weight: 82