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); Appropriate Term/Code Not Available (3191)

Patient Problem Hyperglycemia (1905)

Event Date 09/11/2017

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 she was hospitalized for high blood glucose and ketones.The customer¿s blood glucose level was over 400mg/dl at the time of hospitalization.The customer reported that she had to go to the hospital yesterday because she was not having her transmitter.The customer was hospitalized on (b)(6) 2017 at 2pm.The customer reported that she was not having her sensors and that her pump ran out of insulin when she got to work, her mini fridge went out, the insulin went bad and then she ended up going to the emergency room.She then had fluids and intravenous insulin and then was sent home the same day when blood glucose was stabilized.The customer declined troubleshooting for high blood glucose.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: 6883406
• MDR Text Key: 86984665
• Report Number: 2032227-2017-51184
• 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: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• 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: HG1RFKN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2017
• Date Device Manufactured: 03/27/2017
• 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): Hospitalization
• Patient Age: 31 YR
• Patient Weight: 147