MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-523RNAH

Device Problem Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Customer reported via phone call that insulin pump¿s screen was very badly scratched.Customer stated that they are not able to read the screen.Customer¿s current blood glucose was not given.Customer advised to discontinue use of the pump and revert to a back-up plan.Insulin pump will be return for analysis.

Manufacturer Narrative

The pump had severely scratched display window.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAH
• 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: 7435531
• MDR Text Key: 105673802
• Report Number: 3004209178-2018-65523
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169513068
• UDI-Public: (01)00643169513068
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

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-523RNAH
• Device Catalogue Number: MMT-523RNAH
• Device Lot Number: A1523RNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/17/2018
• Supplement Dates Manufacturer Received: 08/06/2018
• Supplement Dates FDA Received: 08/28/2018
• 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
• Patient Age: 53 YR
• Patient Weight: 115