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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The insulin pump was received with up arrow button unresponsive due to j2/lcd keypad connector unlocked.Unable to confirm motor error alarm, excessive no delivery alarm or perform the self test, unexpected error test, displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery tests due to button keypad anomaly.Pump passed stop current test.Motor passed motor test.Pump had cracked battery tube threads, reservoir tube lip, cracked case at reservoir tube window corner and minor scratched display window.
Event or Problem Description
The customer reported via phone call that the insulin pump alarmed motor error and no delivery.The customer was assisted with motor error troubleshooting.The customer¿s blood glucose level was unknown at the time of the incident.The drive support cap appeared normal.The customer stated that they had an x-ray on their finger while having the insulin pump on.The customer was able to complete pump rewind, but the alarm history contained more than one motor error alarm within the last 30 days.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.Troubleshooting for no delivery was declined.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
• MDR Report Key: 7054867
• Report Number: 2032227-2017-67973
• Device Sequence Number: 13962461
• 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): 11/22/2017

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: 08/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 193