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

Model Number	MMT-523RNAH
Medical Device Problem Codes	Premature Discharge of Battery (1057); Mechanical Problem (1384); Loss of Data (2903); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	03/28/2019
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.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.(b)(4).
Event or Problem Description
Information received by medtronic indicated that the insulin pump had motor error.Customer reported the insulin pump had cracked at the corner of battery compartment.There was no damaged to the reservoir lip ring.No harm requiring medical interventions was reported.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test, self test, rewind, a21 alarm, basic occlusion, occlusion, prime/a33 and excessive no delivery test.No unexpected a17 and a21 alarm anomalies noted.No motor error alarm noted.Motor passed motor test.Device received with cracked case at the display window corners, cracked lcd window, cracked battery tube threads and cracked reservoir tube lip.The test infusion set and reservoir does lock into place.This mdr related to the (b)(4) manufacturing site has been assigned a medwatch number from the medtronic minimed (b)(4) site, per variance 5.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAH
• 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: 9931987
• Report Number: 3004209178-2020-95211
• Device Sequence Number: 3882036
• Product Code: OYC
• UDI-Device Identifier: 00643169513068
• UDI-Public: (01)00643169513068
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/06/2020

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-523RNAH
• Device Catalogue Number: MMT-523RNAH
• Device Lot Number: A1523RNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: 03/28/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 158