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 Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2017

Event Type  malfunction  

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.The device will be returned for analysis and 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 the insulin pump alarmed power system error.The customer¿s blood glucose level was 118 mg/dl at the time of the call.Customer states that this has been happening for a month and a half now.The power system error alarm goes off every 4 hours.If the customer puts in new batteries, the alarm would stop for 24 hours and would start alarming again.The customer stated that the insulin pump was exposed to temperatures below 41°f.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.

Manufacturer Narrative

Pump passed the sleep current measurement, and active current measurement.Pump trace download analysis confirmed the pump alarmed power error (b)(4).The power management tool confirmed power error (b)(4) was triggered battery loaded voltage was less than 3.5 volts for four consecutive hours due to connector resistance at the printed circuit board.After disconnecting and reconnecting the internal battery connector on the printed circuit board, the pump was monitored and functioned properly.No unexpected low battery alarms or replace battery now alarms noted during testing.Pump received with missing retainer, missing reservoir tube o-ring, scratched case, pillowing keypad overlay, and minor scratched lcd window.Unable to perform the displacement test due to missing retainer.

• 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: 6850779
• MDR Text Key: 85298736
• Report Number: 2032227-2017-45815
• 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
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG1LZCN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2017
• 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 Age: 31 YR
• Patient Weight: 135