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 Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 04/14/2018

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

Customer reported via phone call for high blood glucose. Blood glucose was 586 mg/dl. Customer¿s blood glucose was 213 mg/dl. Customer reported that cgm said his blood glucose was 105 mg/dl or so, took a blood glucose was 98 mg/dl close and then went out had dinner with daughter came back and now took a look at insulin pump said that blood glucose was about 110 mg/dl got up this morning looked at the insulin pump again measured 110 mg/dl exactly the historical line was straight blood glucose was 586 mg/dl. Customer reported that after changing sensor, waited a few hours after blood glucose was got it down to 97 mg/dl or 96 mg/dl. Customer measure blood glucose after some times and the blood glucose value was 110 mg/dl and 240 mg/dl. Customer reported that last night blood glucose was up over 500 mg/dl and cgm was saying it was 100 mg/dl that¿s absurd. Customer reported that the sensor last night never recovered, blood glucose was up around 375 mg/dl when changed it out just giving himself insulin based on finger sticks didn¿t want to calibrate until decent blood glucose range, starts to calibrate when blood glucose is 220 mg/dl causes problems with sensor. Customer declined to troubleshoot for high blood glucose because ate too much and didn¿t count carbs before he ate. 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
• MDR Report Key: 7592323
• Report Number: 3004209178-2018-80107
• 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
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG2614B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/15/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 12/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Patient Age: 69 YR
• Patient Weight: 270
• Patient Outcome(s): Other