MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAP; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751NAP

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); High Test Results (2457)

Patient Problem Hyperglycemia (1905)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

The customer reported via phone call that they experienced high blood glucose.The customer¿s blood glucose level was 514 mg/dl.The customer was treated with insulin pens.Customer also reported that lcd screen was damaged.Customer was always high because she cannot read the screen so she cannot bolus.The customer declined troubleshoot for high blood glucose.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device received with intermittent button response due to flattened dome switch on up arrow and down arrow button.Connector was inspected and locked on lcd board.No button error alarm during testing.Device passed displacement test, self test, rewind test, basic occlusion test, prime test, excessive no delivery test and occlusion test.Device received with corroded battery tube and minor scratches on display window noted.

• Brand Name: 530G INSULIN PUMP MMT-751NAP
• 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: 7640459
• MDR Text Key: 112418545
• Report Number: 3004209178-2018-85365
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503700
• UDI-Public: (01)00643169503700
• 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
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAP
• Device Catalogue Number: MMT-751NAP
• Device Lot Number: A4751NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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: 22 YR
• Patient Weight: 167