MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LCMH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-754LCMH

Device Problems Moisture Damage (1405); Device Inoperable (1663); Component Missing (2306); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2017

Event Type  malfunction  

Manufacturer Narrative

The insulin pump had blank display due to moisture damage on electronics.Unable to perform idle current test, run current test, self test, off no power test, unexpected restart error test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test due to blank display.No moisture damage on motor noted.The pump had dented display window, severely scratched display window and cracked reservoir tube lip.The insulin pump involved in this event is the paradigm real-time veo insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.

Event Description

(b)(4): complaint notification notes: call taken by (b)(6) on (b)(6) 2017.Phone # for tracking updates: (b)(6).Init notes: caller is at a waterpark and their insulin pump got drenched in water and is not working anymore.Additional notes: cust also sts that when he filled cannula, he didn't see insulin come out, adv that he may not see drops necessarily as he ran 1.7u though.Cust sts the pump is responsive and working.Repl pump due to cosmetic damage as cust mentions chips of plastic missing from pump screen.Cust declined further t/s for moisture exposure.Cust requested blue pump, sent blue pump.Cust requested alternate delivery address: c/o (b)(6) pump exposed to fluid t/s per (b)(6).Customer reports the type of fluid/moisture exposure to the pump is: pool water.Customer reports how the fluid/moisture exposure occurred is: cust forgot he was wearing the pump.Customer's outcome pertaining to the complaint: cust declined further t/s.Inquired what led up to the complaint.Customer response: cust dropped pump once and the screen has chips missing and scratches.Bumped/dropped/cosmetic damage t/s per (b)(6).Adv to d/c from the pump.Type of damage: chips in the screen and a lot of scratches.Location of the damage: screen.How damage occurred: dropped the pump.Customer reports damage to the pump.Details of the damage: cust dropped pump and there are now chips in the plastic of screen and scratches.Adv to discontinue use of the pump and revert to a back-up plan per hcp's instruction.Adv the pump will need to be replaced.Explained the interaction aftercare email.Item - 'review the pump care best practices listed within the t/s guide' reason not completed - did not discuss.Customer's outcome pertaining to the complaint: adv that the pump needs to be repl.Ship: 1 pump return: 1 pump country: (b)(6) input date: 07/25/2017 warranty start: 05/23/2016 warranty end: 05/22/2020 batch - pcr688844h.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LCMH
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386
• MDR Report Key: 7594651
• MDR Text Key: 111907507
• Report Number: 3004209178-2018-80279
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2018

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
• Device Operator: Lay User/Patient
• Device Model Number: MMT-754LCMH
• Device Catalogue Number: MMT-754LCMH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1