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

Model Number	MMT-751PNAL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the insulin pump had a keypad anomaly.The customer¿s blood glucose was 135 mg/dl at the time of incident.Customer stated that the insulin pump numbers were scrolling while trying to enter the blood glucose reading manually.Customer also reported that the insulin pump shut off while having the keypad issue.The insulin pump is being replaced and is expected to return for analysis.
Additional Manufacturer Narrative
The insulin pump was received with intermittent button response due to corroded keypad traces.No button error alarm during testing.No ramping numbers noted on the display.Pump passed displacement test, self test, unexpected restart error test, off no power test and all operating currents tested within the specification range.The insulin pump was monitored and tested with no off no power alert and blank display noted.The insulin pump was received with corroded battery tube noted.

• Brand Name: 530G INSULIN PUMP MMT-751PNAL
• 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: 7241577
• Report Number: 3004209178-2018-48246
• Device Sequence Number: 164364
• Product Code: OZO
• UDI-Device Identifier: 00643169417076
• UDI-Public: (01)00643169417076
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 09/12/2018

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-751PNAL
• Device Catalogue Number: MMT-751PNAL
• Device Lot Number: A2751PNAL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 180