MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1714K

Device Problems No Display/Image (1183); Moisture Damage (1405); Device Inoperable (1663); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2017

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 that the insulin pump was exposed to moisture and had blank display.The customer¿s blood glucose was 93.6 mg/dl at the time of the incident.The customer reported that he was swimming with the insulin pump.The customer reported that he noticed that the display was blank.Troubleshooting was not performed at the time of call because the customer reported that the insulin pump was not working.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

Unit received with blank display due to corroded electronic assemblies.Unit received with corroded battery tube and corroded motor home switch.Unit received with minor scratches on case, cracked case corner of the belt clip rails near the battery compartment, cracked retainer, stained serial number label and minor scratches on lcd window.

• Brand Name: PUMP MMT-1714K 630G BLACK MMOL CANADA
• 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: 6953614
• MDR Text Key: 89838700
• Report Number: 2032227-2017-59058
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169782396
• UDI-Public: (01)00643169782396
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1714K
• Device Catalogue Number: MMT-1714K
• Device Lot Number: HG1T8Q2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/16/2017
• Supplement Dates Manufacturer Received: 10/10/2017
• Supplement Dates FDA Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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