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 Problem Bent (1059)

Patient Problems Hyperglycemia (1905); Blood Loss (2597)

Event Date 05/29/2018

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

The customer reported via phone call that they had experienced high blood glucose level.The customer¿s blood glucose was 376 mg/dl at the time of the incident and current blood glucose was 548 mg/dl.The customer¿s blood glucose was over 600 mg/dl, 597 mg/dl, 573 mg/dl and 72 mg/dl.The customer was treated with insulin pump.The customer had symptoms such as thirsty.The customer declined troubleshooting.The customer does not allege pump was under delivering.The customer was advised that site related issues, such as bent cannulas tend to be contributing factors in high blood glucose.The insulin pump will not be returned for analysis.

• 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: 7640807
• MDR Text Key: 112420939
• Report Number: 3004209178-2018-85520
• 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
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523NAS
• Device Catalogue Number: MMT-523NAS
• Device Lot Number: B4523NASJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/27/2018
• Date Device Manufactured: 09/08/2016
• 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: PARADIGM QUICK SET MMT-396
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 73