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

Model Number	MMT-523LNAB
Medical Device Problem Codes	No Display/Image (1183); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received with blank display, problem isolated to lcd board.Unable to perform operating currents, self-test, unexpected restart error, rewind, basic occlusion, occlusion, prime/compromised force sensor system, excessive no delivery and displacement test due to blank display.The device had broken battery tube threads.
Event or Problem Description
Customer reported via phone call that they experienced high blood glucose level.Customer's blood glucose level was at 392 mg/dl the time of incident.Customer treated high blood glucose level with manual injection.Customer did not report any symptoms related to the high blood glucose level.Customer reported that the insulin pump had blank display.Customer stated that the battery compartment was cracked.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAB
• 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: 8104392
• Report Number: 2032227-2018-66771
• Device Sequence Number: 11267104
• Product Code: OYC
• UDI-Device Identifier: 00643169151277
• UDI-Public: (01)00643169151277
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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
• Report Date (Section B): 11/26/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-523LNAB
• Device Catalogue Number: MMT-523LNAB
• Device Lot Number: A2523LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 11/26/2018
• 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: 13 YR
• Patient Weight: 45