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

Model Number	MMT-751PNAB
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/02/2017
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.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
The customer reported via phone call that they had multiple no delivery alarms for the last 3 days.The customer's blood glucose level was unknown.The customer stated the alarm did not occur during the manual prime.The customer reported that the event was resolved by changing the complete infusion and reservoir set.The customer did not have the product in question to return.The customer also reported that they had a stuck button.When they tried to clear the alarms, the up arrow button was sticking.It was stuck and it kept flipping back and forth between the options on the insulin pump.They were advised to observe the time clock for one minute to verify if time advances.The customer verified that time advanced.The customer was advised to discontinue use of the device and revert to a back-up plan.The customer was advised that the device would be replaced and agreed to return the product for analysis.
Additional Manufacturer Narrative
Findings: pump was received with act and up buttons unresponsive due to lcd keypad connector unlocked.Unable to verify excessive no delivery alarm or perform the self test, error test, displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery tests due to button keypad anomaly.Pump passed stop current test.Pump had cracked case at display window corner, minor scratched and cracked display window.

• Brand Name: 530G INSULIN PUMP MMT-751PNAB
• 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: 6677508
• Report Number: 2032227-2017-24839
• Device Sequence Number: 10809791
• Product Code: OZO
• UDI-Device Identifier: 00643169507319
• UDI-Public: (01)00643169507319
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/08/2017

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-751PNAB
• Device Catalogue Number: MMT-751PNAB
• Device Lot Number: A3751PNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 190