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
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2017
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.Pump passed unexpected restart error test.No unexpected restart alarm noted.Pump received with reservoir tube lip completely broken off.The test reservoir does not stay locked in place due to reservoir tube lip broken off.Unable to perform displacement test due to reservoir lip broken off.
Event or Problem Description
The customer reported via phone call that the insulin pump had a pump error alarm.The customer¿s blood glucose was 155 mg/dl.The device will be returned for the analysis.

• 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: 8380694
• Report Number: 3004209178-2019-60911
• Device Sequence Number: 18892226
• Product Code: OYC
• UDI-Device Identifier: 00643169077645
• UDI-Public: (01)00643169077645
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2019

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: 09/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 68