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

Model Number	MMT-751NAL
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Mechanical Problem (1384); Device Difficult to Program or Calibrate (1496); Patient Device Interaction Problem (4001); Priming Problem (4040)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
The customer reported via phone call that the insulin pump had keypad anomaly and prime anomaly.The customer¿s blood glucose level was unknown.The customer reported that the act button during priming stopped working and had to press multiple times to respond.It was reported that the pump screen had scratches on the display that effected the ability to see screen fully.It was reported that they had to rewind twice during priming of the pump.The customer was advised the pump will need to be replaced.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device display properly and no missing segment/partial display anomaly noted.However, device had unresponsive buttons due to flattened (creased) act and up buttons dome switch.No unlocked lcd keypad connector noted.Unable to perform operating currents, self-test, a21 error test, rewind test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test or verify prime/fill, rewind anomaly due to unresponsive button.Device had minor scratched lcd window, cracked battery tube threads.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-751NAL
• 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: 8103662
• Report Number: 2032227-2018-66409
• Device Sequence Number: 1098320
• Product Code: OZO
• UDI-Device Identifier: 00643169736085
• UDI-Public: (01)00643169736085
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 11/22/2019

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-751NAL
• Device Catalogue Number: MMT-751NAL
• Device Lot Number: A6751NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 70