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

Model Number	MMT-523LNAP
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	06/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pump had cracked case at display window corners, battery tube threads, reservoir tube lip completely broken off and test reservoir will not lock/click in place, minor scratched and cracked display window.Unable to perform the basic occlusion and occlusion tests due to reservoir tube lip anomaly.Pump passed the operating currents measurement, self test, unexpected restart error test, displacement, prime and excessive no delivery tests.
Event or Problem Description
The customer reported via phone call that they were experiencing high and low blood glucose levels.Customer also reported that the reservoir compartment of the device was damaged and the reservoir would not lock into place.Blood glucose level at the time of the incident was 300 mg/dl which was treated with a bolus.The following morning, the customer's blood glucose level was 50 mg/dl after taking a bolus at 7:00 am.Customer treated with food and glucose tablet.Customer declined troubleshooting.The customer was advised the insulin pump will be replaced and agreed to return the product for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAP
• 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: 6756556
• Report Number: 2032227-2017-32752
• Device Sequence Number: 983711
• Product Code: OYC
• UDI-Device Identifier: 00643169479623
• UDI-Public: (01)00643169479623
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/01/2017

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-523LNAP
• Device Catalogue Number: MMT-523LNAP
• Device Lot Number: A3523LNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 08/01/2017
• 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: 128