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

Model Number	MMT-751RNAP
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/15/2018
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.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 on (b)(6) 2018 that the insulin pump had scratches on the lcd screen making it hard to read.Blood glucose level at the time of incident was 342 mg/dl and was treated with manual injection.Trouble shooting completed.Product will be returned for analysis and replacement has been sent.
Additional Manufacturer Narrative
Insulin pump passed the displacement, self test and passed the delivery accuracy test at 0.08720 inches noted.No missing segment/partial display anomaly during test.Insulin pump received with minor scratched lcd window.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-751RNAP
• 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: 7858853
• Report Number: 2032227-2018-25156
• Device Sequence Number: 1966388
• Product Code: OZO
• UDI-Device Identifier: 00643169507999
• UDI-Public: (01)00643169507999
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/13/2018

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-751RNAP
• Device Catalogue Number: MMT-751RNAP
• Device Lot Number: A3751RNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 09/09/2018
• Supplement Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 180