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

Model Number	MMT-523NAB
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2018
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 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
Customer¿s mother was reported via phone call that, the insulin pump had off no power alarm and had blank display screen also.The blood glucose was 154 mg/dl at the time of the incident.Customer stated that, they did receive a low battery alert prior to the off no power alert.Customer changed battery last week and 10-15 minutes ago the alarm showed powering off.New battery resolved the issue.Assisted customer with blank display troubleshooting and troubleshooting determined that, the insulin pump should be replaced.The customer advised to discontinue use of the pump and revert to a back-up plan.The insulin device will not be returned for analysis.
Additional Manufacturer Narrative
Device power up properly after battery installation.Device received with operating currents within specs.No unexpected low battery alarms were noted during testing.Device passed displacement test and unexpected restart error test and all operating currents test.Insulin pump received with cracked display window corners noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB
• 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: 7236388
• Report Number: 3004209178-2018-47930
• Device Sequence Number: 19099165
• Product Code: OYC
• UDI-Device Identifier: 00643169077645
• UDI-Public: (01)00643169077645
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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-523NAB
• Device Catalogue Number: MMT-523NAB
• Device Lot Number: A7523NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 40