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

Model Number	MMT-751PNAH
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Mechanical Problem (1384); Obstruction of Flow (2423); Power Problem (3010); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2018
Type of Reportable Event	Malfunction
Additional 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.Pump received with intermittent button response due to partial unlocked j2/lcd keypad connector noted during visually inspect.Unable to perform all functional testing including the displacement, operating currents, a21 error test, rewind, basic occlusion, occlusion, prime/a33 and excessive no delivery test or verify failed battery test alert, unexpected battery power loss anomaly, no delivery alarm, drive/motor anomaly, rewind anomaly and back light anomaly due to buttons not responding.Pump received with cracked case reservoir tube window corner.
Event or Problem Description
The customer reported via phone call that insulin pump rejects new batteries, motor sluggish during rewind and also had random no delivery alarm.The customer's blood glucose value was unknown.The customer also reported reservoir window was crack and backlight was dimmer.Esc button has to be pushed in specific area to work.The insulin pump will be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751PNAH
• 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: 8373041
• Report Number: 3004209178-2019-60150
• Device Sequence Number: 2287929
• Product Code: OZO
• UDI-Device Identifier: 00643169507326
• UDI-Public: (01)00643169507326
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 02/27/2019

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-751PNAH
• Device Catalogue Number: MMT-751PNAH
• Device Lot Number: A3751PNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 243