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

Model Number	MMT-723RNAP
Medical Device Problem Codes	No Display/Image (1183); Obstruction of Flow (2423); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2020
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
Information received by medtronic indicated that they insulin pump had blank display.No harm requiring medical intervention was reported.Customer received no delivery alarm but then did not turn back on.Customer stated that insulin pump was not exposed to moisture.The customer was assisted with troubleshooting and customer reports display was blank currently.Customer stated the display was not blank less than 30 seconds and did not return.The customer removes the battery and stated the insert battery alarm did not display on the insulin pump screen.Customer stated the contact on the battery cap was neither missing nor damage, only the coin slot of the battery cap was worn out.Customer stated battery compartment was neither damaged nor corroded.Customer stated the spring was neither damaged nor corroded.Customer stated that display did not returned after insulin pump restart.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device power up properly after battery installation.No blank display or display anomaly noted.However, device alarmed failed battery test due to corroded battery tube.Unable to perform operating currents, self-test, a21 error, rewind test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test or verify no delivery alarm due to failed battery test alarm.Unable to verify battery cap damage due to battery cap not come with unit.(b)(4).

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAP
• 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: 10281097
• Report Number: 2032227-2020-147164
• Device Sequence Number: 2576933
• Product Code: OYC
• UDI-Device Identifier: 00643169513136
• UDI-Public: (01)00643169513136
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 09/29/2020

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-723RNAP
• Device Catalogue Number: MMT-723RNAP
• Device Lot Number: A1723RNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 222