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

Model Number MMT-754LWWS

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2018

Event Type  malfunction  

Manufacturer Narrative

Insulin pump was received with no button response at esc, act, up and down due to unlocked lcd keypad connector during visual inspection.Unable to perform operating currents, self-test and displacement test due to no button response.No button error alarm during testing.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to the paradigm real-time insulin infusion pump, which is marketed in the united states.The asr exemption e2015043 was revoked on february 4, 2019.This event was previously reported as an asr.Additional information or analysis results regarding this event will be reported as an mdr.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 Description

It was reported that the customer insulin pump had keypad anomaly.The customer¿s blood glucose level was 10 mmol/l.The customer reported that the escape button was not responsive and time was advanced on the screen.The customer was advised to discontinue use of the pump and revert to backup plan per health care professional instructions.The insulin pump will be returned for analysis.

Manufacturer Narrative

The date provided with the initial report was incorrect.The correct date is (b)(6 2019.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LWWS
• 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 ; 8185464805
• MDR Report Key: 8344319
• MDR Text Key: 136603007
• Report Number: 3004209178-2019-56348
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169495593
• UDI-Public: (01)00643169495593
• Combination Product (y/n): N
• Reporter Country Code: KU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-754LWWS
• Device Catalogue Number: MMT-754LWWS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2014
• 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