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

Model Number	MMT-723LNAP
Medical Device Problem Codes	Device Alarm System (1012); No Display/Image (1183); Material Integrity Problem (2978); Moisture or Humidity Problem (2986); Power Problem (3010); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Insulin pump received with blank display due to moisture damage at electronic assembly.Also, moisture damage motor during visual inspection.Unable to perform operating currents, self test, rewind test and displacement test or verify battery out limit due to blank display.Pump received with stripped battery cap coin slot(p).
Event or Problem Description
Customer reported via phone call that insulin pump was not working after water damage as well as constantly alarming before shutting down.Customer¿s blood glucose was unknown.Customer stated that insulin pump display went blank immediately after pump exposure to moisture and cap was worn or damaged.Customer stated that insulin pump fell into the ice chest was in an ice pack and fell into the ice chest was in an ice pack and insulin pump was vibrating without an alarm or alert.Customer was advised to discontinue use of insulin pump and revert to back up plan.Insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAP
• 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: 8987708
• Report Number: 2032227-2019-60252
• Device Sequence Number: 16940256
• Product Code: OYC
• UDI-Device Identifier: 00643169478596
• UDI-Public: (01)00643169478596
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2019

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-723LNAP
• Device Catalogue Number: MMT-723LNAP
• Device Lot Number: A4723LNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 91