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

Model Number MMT-751NAB

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Deliver (2338); Device Displays Incorrect Message (2591); Battery Problem (2885); Failure of Device to Self-Test (2937); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

The customer reported via phone call the insulin pump had multiple issues.The customer¿s blood glucose was unknown at the time of incident.Customer stated that the insulin pump had scratches on the screen, battery does not last long, had a failed battery test and no delivery alarm, buttons were unresponsive.No troubleshooting was performed.The insulin pump is not expected to return for analysis.

Manufacturer Narrative

Device had unresponsive up button due to unlocked lcd keypad connector.Unable to perform operating currents, self-test, a21 error test, rewind test, basic occlusion test, occlusion test, prime or a33 test, excessive no delivery test and displacement test or verify no delivery, failed battery test alarm due to unresponsive button.Device had minor scratched lcd window.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-751NAB
• 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: 7624067
• MDR Text Key: 111837518
• Report Number: 3004209178-2018-83705
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169404304
• UDI-Public: (01)00643169404304
• 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: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAB
• Device Catalogue Number: MMT-751NAB
• Device Lot Number: A2751NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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: 22 YR
• Patient Weight: 140