MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-723LNAS

Device Problems Failure to Infuse (2340); Physical Resistance (2578)

Patient Problem Hyperglycemia (1905)

Event Date 08/07/2017

Event Type  Injury  

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

Customer reported via phone call no delivery and high blood glucose.The customer's blood glucose was 400 mg/dl at the time of call.Trouble shooting was performed and advised to disconnect, remove reservoir and run manual prime.Customer reports insulin does not exit and there is greater than normal resistance with plunger push.Advised to reinsert reservoir and run manual prime until at least 5.0 units and they observe insulin exiting the tubing or pump alarms.Customer reports insulin exits with the manual prime.Advised the insulin pump is working as designed.It was found that most likely a connection issues caused the lack of insulin delivery.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS
• 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: 7628466
• MDR Text Key: 111983104
• Report Number: 3004209178-2018-84212
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169513914
• UDI-Public: (01)00643169513914
• 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: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723LNAS
• Device Catalogue Number: MMT-723LNAS
• Device Lot Number: A5723LNASJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: MMT-332A
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 170