MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551PNAH; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-551PNAH
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2017
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 the insulin pump had low battery and sensor end alerts.The customer¿s blood glucose was 150 mg/dl at the time of the incident.The customer states they were trying to rewind but the insulin pump began to alarm.The customer stated the buttons were hard to push and now they are not working.The customer was advised to observe time clock for one minute to verify if time advances, found time is still advancing.Customer was also calling back after letting the insulin pump rest for two hours due to a constant tone.Customer stated the buttons were not functional.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
All buttons did not respond due to flattened button dome switches.No unlock on lcd keypad connector noted.Pump passed idle current test.Unable to perform run current test, self test, off no power test, unexpected restart error test, basic occlusion test, occlusion test, prime test, excessive no delivery test, displacement test or verify low battery alarm due to button keypad anomaly.No frozen screen, constant tone alarm, or vibration anomaly noted.Pump had minor scratched display window.

• Brand Name: 530G INSULIN PUMP MMT-551PNAH
• 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: 6658422
• Report Number: 2032227-2017-22503
• Device Sequence Number: 16161063
• Product Code: OZO
• UDI-Device Identifier: 00643169507272
• UDI-Public: (01)00643169507272
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/17/2017

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-551PNAH
• Device Catalogue Number: MMT-551PNAH
• Device Lot Number: A3551PNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 118