MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAS; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-551NAS

Device Problems Improper or Incorrect Procedure or Method (2017); Moisture or Humidity Problem (2986); Noise, Audible (3273)

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.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 the insulin pump was exposed to moisture.The customer¿s blood glucose was unknown at the time of the incident.The customer states the insulin pump was exposed to moisture.Customer stated they a constant tone was occurring.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan a replacement will be sent.The insulin pump will be returned for analysis.

Manufacturer Narrative

Findings: pump received with blank display and constant tone due to moisture damage on the electronics assembly.Unable to perform all functional testing including the operating currents, unexpected alarm error test, rewind, basic occlusion, occlusion, prime and excessive no delivery test due to blank display.Pump received with moisture damage motor, vibrator, keypad and battery tube assembly.Pump received with cracked case at the display window corner, cracked reservoir tube lip, minor scratched lcd window, missing end cap sticker, cracked case reservoir tube window corner and cracked battery tube threads.

• Brand Name: 530G INSULIN PUMP MMT-551NAS
• 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: 6850341
• MDR Text Key: 85576571
• Report Number: 2032227-2017-45686
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169404298
• UDI-Public: (01)00643169404298
• 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: 11/15/2017

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-551NAS
• Device Catalogue Number: MMT-551NAS
• Device Lot Number: A2551NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2017
• 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
• Patient Age: 46 YR
• Patient Weight: 125