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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit received with operating currents within specification.Unit passed self test, a21 error test, displacement test and basic occlusion test.Unable to prime unit during prime/a33 test due to faulty fsr (gold).Unable to perform occlusion test, dat test and excessive no delivery test due to prime anomaly.Unit received with corroded battery tube.Unit received with cracked case at display window corners, display window, reservoir tube lip and battery tube threads.Unit received with minor scratched display window and case.Unit received with stained end cap sticker and back address serial number label.
Event or Problem Description
Information received by medtronic indicated that daughter of the customer had high blood glucose.The blood glucose of customer was 339 mg/dl at the time of the incident.Customer had been using insulin pump system within 48 hours of reported high blood glucose level event.Customer was not alleging insulin pump was under delivering.No harm requiring medical intervention was reported.The insulin pump will be returned 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; * 00777-3869
• MDR Report Key: 9941889
• Report Number: 3004209178-2020-96648
• Device Sequence Number: 16967448
• Product Code: OYC
• UDI-Device Identifier: 00643169932975
• UDI-Public: (01)00643169932975
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2020

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-523LNAP
• Device Catalogue Number: MMT-523LNAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1