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

Model Number MMT-751NAS

Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2017

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 when they went to bed the insulin pump had a low battery but they forgot to change the battery.When they woke up they used 3 batteries but the screen was still blank.The customer¿s blood glucose was 210 mg/dl.Troubleshooting was performed.The device was not bumped or dropped.The device was not exposed to moisture.They inserted a new battery but the display did not return.They put on a new battery cap but the display did not return.The customer was advised to discontinue use of the device and revert to a back-up plan.The customer was advised that the device would be replaced and agreed to return the product for analysis.

Manufacturer Narrative

A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.Insulin pump passed the functional testing, including the operating currents measurement, self-test, unexpected restart error test, displacement, rewind, basic occlusion, occlusion, prime/compromised force sensor system and excessive no delivery test.Insulin pump was monitored for several days and no blank display anomaly noted.No damage found on lcd isolation tape noted.Insulin pump had cracked case at display window corners, battery tube threads, broken reservoir tube lip, cracked belt clip slot, missing reservoir tube o-ring, minor scratched and cracked display window, and missing end cap sticker.

• Brand Name: 530G INSULIN PUMP MMT-751NAS
• 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: 6876921
• MDR Text Key: 87634894
• Report Number: 2032227-2017-50005
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503717
• UDI-Public: (01)00643169503717
• 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: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAS
• Device Catalogue Number: MMT-751NAS
• Device Lot Number: A4751NASJ
• 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: 01/10/2018
• 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
• Patient Age: 65 YR
• Patient Weight: 217