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

Model Number	MMT-523RNAP
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pump passed functional testings including displacement test, rewind test, basic occlusion test, occlusion test, prime/delivery test and excessive no delivery test.Drive support disk was inspected and no anomaly noted.Unit was received with normal operating currents and no unexpected off no power alarm or low battery alarm noted.Unit passed the dat test.Pump was received with cracked case at display window corner, minor scratched lcd window, cracked battery tube threads, cracked reservoir tube lip and stained address/serial number label.
Event or Problem Description
The customer reported via phone call that customer's wife was hospitalized due to high blood glucose on (b)(6) 2018 with blood glucose was 453 mg/dl.The current blood glucose is 59 mg/dl.The customer treated their high blood glucose with manual injection and insulin drip.The customer reported that the drive support cap was normal.Based on customer report customer does not allege pump was under delivering.The insulin pump passed the high pressure test.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP
• 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: 7318040
• Report Number: 3004209178-2018-54879
• Device Sequence Number: 13482738
• Product Code: OYC
• UDI-Device Identifier: 00643169476493
• UDI-Public: (01)00643169476493
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 03/06/2018

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-523RNAP
• Device Catalogue Number: MMT-523RNAP
• Device Lot Number: A0523RNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2018
• Initial Report FDA Received Date: 03/06/2018
• 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: Hospitalization
• Patient Age: 83 YR
• Patient Weight: 109