MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523LNAL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2016
Type of Reportable Event	Serious Injury
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's clinical specialist reported via phone call the insulin pump alarmed motor error and a no delivery alarm.The caller stated the customer just came from the emergency room and was currently at the doctor's office.The caller reported the customer had high blood glucose and did not know how to treat.The nurse did not provide their blood glucose value at the time of the incident.During trouble shooting a motor error and recurring no delivery alarms were found.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The insulin pump passed all functional testing including the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test.No excessive no delivery/occlusion alarm noted.No motor error alarm noted.Motor passed motor test.The insulin pump was received with minor scratched lcd window, cracked case at the display window corners, broken battery tube threads and cracked reservoir tube lip.A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAL
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 6633728
• Report Number: 3004209178-2017-54542
• Device Sequence Number: 13108
• Product Code: OYC
• UDI-Device Identifier: 00643169479616
• UDI-Public: (01)00643169479616
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2017

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-523LNAL
• Device Catalogue Number: MMT-523LNAL
• Device Lot Number: A3523LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 08/14/2017
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 155