MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-523LNAP

Device Problems Break (1069); Component Missing (2306); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

S/v 2.5a.Pump received with cracked case at the display window corner, broken reservoir tube lip, minor scratched lcd window, stained end cap sticker, stained address/serial number label, cracked belt clip slot, cracked case reservoir tube window corner, cracked lcd window, missing reservoir tube o-ring, broken battery tube threads and cracked reservoir tube window.

Event Description

It was reported via phone call that customer¿s insulin pump had damaged.Customer¿s blood glucose was unknown at time of incident.Customer states that half of top of reservoir compartment was missing.Customer also reported in insulin pump had scratched screen.Customer advised to discontinue use of the pump and revert to a back-up plan per hcp's instruction.Insulin pump will be return for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAP
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 7489669
• MDR Text Key: 107576032
• Report Number: 2032227-2018-02924
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169151307
• UDI-Public: (01)00643169151307
• 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
• Report Date: 05/07/2018

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-523LNAP
• Device Catalogue Number: MMT-523LNAP
• Device Lot Number: A000289850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2013
• 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: 52 YR
• Patient Weight: 56