MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723NAB
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device received with no (act, up and escape) button response due to corroded keypad traces.No button error alarm during testing noted.Unable to perform all functional testing including the displacement, operating currents, unexpected restart error test, rewind, basic occlusion, occlusion, prime /compromised force sensor system and excessive no delivery test due to buttons not responding.The asr exemption e2015043 was revoked on february 4, 2019.This event was previously reported as an asr.Additional information or analysis results regarding this event will be reported as an mdr.
Event or Problem Description
The customer¿s parent reported via phone call the insulin pump alarmed button error.The customer¿s blood glucose was 295 mg/dl at the time of incident.Customer¿s parent stated that insulin pump alarmed button error and the act button was stuck.No significant events leading to button error were observed.Button error troubleshooting was performed and unable to confirm if the time is advancing due to battery has already been removed.The customer¿s parent was advised to have the customer discontinue use of pump and revert to back-up plan.The insulin pump is being replaced and is expected to return for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB
• 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: 8568054
• Report Number: 3004209178-2019-90859
• Device Sequence Number: 1537465
• Product Code: OYC
• UDI-Device Identifier: 00613994904317
• UDI-Public: (01)00613994904317
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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-723NAB
• Device Catalogue Number: MMT-723NAB
• Device Lot Number: A5723NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 58