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

Model Number	MMT-523LNAH
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2017
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 as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
the customer reported via phone call that they had repeated failed battery test alarm on their insulin pump.The customer stated they have replaced the alarms occurred after every battery replacement.Customer's blood glucose was unknown at the time of the call.The customer also reported cracks on the insulin pump, from the insulin pump's screen to battery compartment.The customer was advised that the device would be replaced.Customer agreed to return the product for analysis. .
Additional Manufacturer Narrative
Findings: unit was received with normal operating currents and no unexpected low battery, battery out limit and failed battery test alarms during testing.Unit passed self-test, unexpected alarm error test, rewind test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test.Unit had minor scratched lcd window, cracked lcd window, cracked case at display window corners, cracked 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-523LNAH
• 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: 6597128
• Report Number: 3004209178-2017-51266
• Device Sequence Number: 13740240
• Product Code: OYC
• UDI-Device Identifier: 00643169479609
• UDI-Public: (01)00643169479609
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

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-523LNAH
• Device Catalogue Number: MMT-523LNAH
• Device Lot Number: A3523LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 05/29/2017
• Supplement Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1