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

Model Number	MMT-751LNAP
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/11/2020
Type of Reportable Event	Serious Injury
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
The customer reported via phone call that they experienced hyperglycemia.Customer¿s blood glucose level was over 600 mg/dl.Customer treated with manual boluses using needles.Customer had using insulin pump system within 48 hours of reported high blood glucose event.Customer does not use auto mode.Customer was neither in emergency room, nor admitted into hospital.Customer alleging possible insulin pump under delivery because she tried to deliver bolus and it¿s not lowering her blood glucose that he still needs to do manual needles.Customer reported that the drive support cap was flush.The devices will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751LNAP
• 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: 9590921
• Report Number: 3004209178-2020-56038
• Device Sequence Number: 2697091
• Product Code: OZO
• UDI-Device Identifier: 00643169933217
• UDI-Public: (01)00643169933217
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751LNAP
• Device Catalogue Number: MMT-751LNAP
• Device Lot Number: A5751LNAPJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2020
• Initial Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Weight: 72