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

Model Number	MMT-751PNAP
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2017
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 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 the insulin pump had a prime and fill anomaly.They were trying to do a set change and deliver a bolus but got stuck in the fill tubing loop.Insulin was squirting out during the manual prime process.The customer¿s blood glucose during the incident was 160 mg/dl.Troubleshooting was performed.They were able to rewind the device.However, the device did not exit the rewind complete/bolus delivery loop and complete the fill tubing process successfully.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Motor error alarm during the basic occlusion test due to faulty force sensor resistor.Unable to confirm prime/fill anomaly due to motor error alarm.Pump received with cracked battery tube thread, cracked reservoir tube lip and minor scratches on display window noted.No moisture damage on electronics and motor assembly noted.

• Brand Name: 530G INSULIN PUMP MMT-751PNAP
• 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: 7080728
• Report Number: 2032227-2017-70029
• Device Sequence Number: 13777597
• Product Code: OZO
• UDI-Device Identifier: 00643169507340
• UDI-Public: (01)00643169507340
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/13/2018

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-751PNAP
• Device Catalogue Number: MMT-751PNAP
• Device Lot Number: A3751PNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Initial Date Received by Manufacturer: 11/05/2017
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 145