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

Model Number MMT-523NAS

Device Problems Break (1069); Detachment Of Device Component (1104); Crack (1135); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2018

Event Type  malfunction  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

The customer reported via phone call that their insulin pump was damaged.The customer¿s blood glucose level was unknown.The customer reported that the reservoir compartment for her pump was cracked and the reservoirs are not staying in the pump very well.The customer reported that a couple of weeks ago part of the reservoir broke off and she found it on the floor, then the other piece broke off and now the reservoir will not stay in the pump.Troubleshooting was performed for damage and noticed the reservoir did not lock in place.Advised the pump will need to be replaced.Advised to discontinue use of the pump and revert to a backup plan.The insulin pump will be returned for analysis.

Manufacturer Narrative

Pump received with broken reservoir tube lip and cracked case at the reservoir tube window.A test reservoir was installed and did not lock in place due to complete broken reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAS
• 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: 7548207
• MDR Text Key: 109550946
• Report Number: 3004209178-2018-74690
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169507203
• UDI-Public: (01)00643169507203
• 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: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523NAS
• Device Catalogue Number: MMT-523NAS
• Device Lot Number: B4523NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2018
• 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: 48 YR
• Patient Weight: 145