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

Model Number MMT-523RNAP

Device Problem Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pump had cracked battery tube threads, broken half of reservoir tube lip, missing reservoir tube o-ring, cracked belt clip slot, cracked case at reservoir tube window corner, cracked case at display window corner, minor scratched and cracked display window.

Event Description

The customer reported via phone call that the plastic was worn away on the reservoir.The customer's blood glucose level was 145 mg/dl at the time of incident.The customer was advised to discontinue the use of insulin pump.The customer will return insulin pump for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP
• 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: 7041650
• MDR Text Key: 92861711
• Report Number: 2032227-2017-66612
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169513082
• UDI-Public: (01)00643169513082
• 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: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523RNAP
• Device Catalogue Number: MMT-523RNAP
• Device Lot Number: A1523RNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2017
• 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: 75 YR
• Patient Weight: 145