MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723RNAL
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
Customer¿s husband reported via phone call that the insulin pump had a blank display.The customer¿s blood glucose level was unknown at the time of the incident.Customer states the contacts on the battery cap are neither missing nor damaged, battery compartment was neither damaged nor corroded and the spring was neither damaged nor corroded.Trouble shooting was performed for blank display.Customer was advised to clean battery cap contacts with a dry cotton swab, if no iso propyl alcohol is available to use an alcohol wipe or dry cotton swab.Advised to allow at least one minute for the battery contacts to dry and to insert new aa battery.Display did not return after pump restart.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The customer was advised the pump will be replaced as per troubleshoot.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump monitored for several days and no blank display noted.Insulin pump received with normal operating current.Insulin pump passed self test.Insulin pump passed off no power test.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAL
• 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: 8726814
• Report Number: 2032227-2019-20545
• Device Sequence Number: 1787867
• Product Code: OYC
• UDI-Device Identifier: 00643169476585
• UDI-Public: (01)00643169476585
• 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): 07/18/2019

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-723RNAL
• Device Catalogue Number: MMT-723RNAL
• Device Lot Number: A0723RNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 06/16/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 72