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 Component Falling (1105); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The insulin pump had a blank display due to moisture damage on lcd board.The device was unable to perform all tests due to blank display.No moisture damage on motor was noted.The pump was received with a minor scratched display window, cracked case at display window corners, cracked battery tube threads, broken reservoir tube lip, cracked reservoir tube and stained end cap sticker.

Event Description

The customer reported via phone call that she had accidentally dropped the insulin pump in a bath tub.The customer¿s blood glucose during the incident was 97 mg/dl.Troubleshooting was performed.The device was returned for analysis.

Manufacturer Narrative

The initial report and or supplemental report had the incorrect aware date.The correct aware date is (b)(4) 2017.

Event Description

The initial report and or supplemental report had the incorrect aware date.The correct aware date is (b)(4) 2017.

• 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: 6930199
• MDR Text Key: 89514669
• Report Number: 2032227-2017-56899
• 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: 02/21/2019

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-751NAP
• Device Catalogue Number: MMT-751NAP
• Device Lot Number: A4751NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/09/2017
• Supplement Dates Manufacturer Received: 02/19/2019
• Supplement Dates FDA Received: 02/21/2019
• 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: 51 YR
• Patient Weight: 224