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

Model Number	MMT-523NAS
Medical Device Problem Codes	Mechanical Problem (1384); Environmental Compatibility Problem (2929); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
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 the insulin pump motor error alarm. customer stated that the insulin pump had motor exposition encoder alarm.Customer stated that the insulin pump was exposed to magnetic resonance image.Customer was not able to clear alarm.Customer stated that battery cap was broken.The insulin pump was turned off.Customer stated that the insulin pump had burned side and broken battery the customer stated that the drive support cap was normal. no harm requiring medical intervention was reported.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the self test and the off no power test.The operating currents were within specification.Device received with stuck motor error alarm loop during bolus/basal delivery, failed the displacement test, and then after the displacement test had constant motor error alarm during the rewind test due to motor encoder signal out of phase.No e70 alarm noted in the alarm history screen.Unable to perform a21 error test, basic occlusion test, prime/a33 test, occlusion test, excessive no delivery test and the delivery accuracy test due to motor error alarms.No burnt case noted.Device had a stained end cap sticker, broken battery cap, broken battery tube threads, cracked case at the display window corner, cracked reservoir tube and cracked reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAS
• 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: 9635715
• Report Number: 3004209178-2020-60759
• Device Sequence Number: 13532919
• Product Code: OYC
• UDI-Device Identifier: 00643169202344
• UDI-Public: (01)00643169202344
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 03/15/2020

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-523NAS
• Device Catalogue Number: MMT-523NAS
• Device Lot Number: B1523NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 130