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

Model Number	MMT-751RNAH
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/12/2017
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.The device has been returned, but not yet evaluated.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 they experienced high blood glucose level of 600 mg/dl.The customer was hospitalized for high readings on (b)(6) 2017 between 9am and 10am.Customer's blood glucose value was 387 mg/dl at the time of the call.Customer reported that the high blood glucose levels began on (b)(6) 2017.Troubleshooting was performed.The drive support cap appeared normal.There were no leaks or air bubbles.There were no site or insulin issues.The device settings were correct.The insulin pump passed the high pressure test.Customer was advised to change the infusion set, reservoir and insulin and to treat per healthcare professional's recommendation.The product was returned for analysis.
Additional Manufacturer Narrative
All operating currents are within specification.No unexpected low battery or off no power alarms noted.Unit passed off no power test, self test, unexpected restart error test, displacement test, rewind, basic occlusion, and excessive no delivery alarm test.Unable to prime during prime test due to faulty force sensor resistor.Unable to complete functional test due to prime anomaly.The insulin pump was received with minor scratched lcd window and cracked reservoir tube lip.

• Brand Name: 530G INSULIN PUMP MMT-751RNAH
• 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: 6695641
• Report Number: 2032227-2017-26887
• Device Sequence Number: 992408
• Product Code: OZO
• UDI-Device Identifier: 00643169507975
• UDI-Public: (01)00643169507975
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2017

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751RNAH
• Device Catalogue Number: MMT-751RNAH
• Device Lot Number: A3751RNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Weight: 203