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

Model Number	MMT-551NAB
Medical Device Problem Codes	No Display/Image (1183); Battery Problem (2885)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Unit power up properly after battery installation.No blank display noted.Unit was received with normal operating currents and passed self-test, unexpected restart error test.No unexpected off no power, weak battery, low battery, battery out limit and failed battery test alarms during testing.However, a test reservoir was installed and did not lock in place due to completely broken reservoir tube lip.Unable to perform the displacement test due to completely broken reservoir tube lip.Unit had missing reservoir tube o-ring.Cracked battery tube threads.
Event or Problem Description
The customer reported via phone call that the insulin pump had a blank display.The customer¿s blood glucose level was unknown.Customer stated that the contacts on the battery cap were not missing or damaged.Customer stated that the battery compartment was neither damaged nor corroded also the spring was neither damaged nor corroded.The display returned.The device will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551NAB
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 9351070
• Report Number: 2032227-2019-120434
• Device Sequence Number: 3541380
• Product Code: OZO
• UDI-Device Identifier: 00643169404250
• UDI-Public: (01)00643169404250
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-551NAB
• Device Catalogue Number: MMT-551NAB
• Device Lot Number: A2551NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 71