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

Model Number	MMT-751LNAH
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2019
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
Customer reported via phone call that the insulin pump had a blank display.The customer¿s blood glucose level was unknown at the time of the incident.The customer was assisted with troubleshooting and customer reports display was blank currently.Customer states tried to place in a new battery but still not working full black screen.Customer states the pump was neither exposed to extreme temperatures nor direct sunlight.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The customer was advised the insulin pump will be replaced as per troubleshoot.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device monitored for several days and no blank display noted.Device received with normal operating current.Device passed self test.Device passed off no power test.No unexpected low battery alarm anomalies noted.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-751LNAH
• 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: 8738658
• Report Number: 2032227-2019-21984
• Device Sequence Number: 2473658
• Product Code: OZO
• UDI-Device Identifier: 00643169933194
• UDI-Public: (01)00643169933194
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 07/31/2019

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-751LNAH
• Device Catalogue Number: MMT-751LNAH
• Device Lot Number: A5751LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 129