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	Insufficient Flow or Under Infusion (2182); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	11/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
The customer reported via phone call that they experienced high blood glucose level.Customer¿s blood glucose level was over 600 mg/dl at the time of incident and current blood glucose level was 429 mg/dl.The customer¿s other blood glucose level was 367 mg/dl at the time of call.The customer did not provide details on symptoms related to the high blood glucose level episodes.Customer was treated with the manual injection.Customer alleges insulin pump was under delivering.Customer also reported that the lip ring from reservoir was crack around the top.Customer stated that the reservoir was able to lock in place when inserted into insulin pump.Customer was not calling back to performed high pressure test.Customer declined to check for the presence of leaks or air bubbles in the tubing or reservoir.Customer stated that the drive support cap was normal.Customer troubleshooting was performed.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Additional information has been received which was not included with the initial report.The information has been provided with this report.The information provided in concomitant reporting section with the initial report was incorrect.The correct information has been included with this report.(b)(4).
Event or Problem Description
It was reported via phone call that the weight has been updated to (b)(6).
Additional Manufacturer Narrative
Device passed prime test and excessive no delivery test.Unable to perform displacement test, basic occlusion, occlusion test and displacement accuracy test due to reservoir tube lip broken off.The test reservoir does not stay locked in place due to reservoir tube lip broken off.Device received with reservoir tube lip completely broken off noted.

• 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: 8098172
• Report Number: 2032227-2018-64606
• Device Sequence Number: 1913513
• Product Code: OYC
• UDI-Device Identifier: 00643169476479
• UDI-Public: (01)00643169476479
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: A0523RNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 11/27/2018; 02/12/2019
• Initial Report FDA Received Date: 11/22/2018
• Supplement Report FDA Received Date: 11/30/2018; 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR