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

Model Number MMT-XXX

Device Problems Device Inoperable (1663); Electromagnetic Compatibility Problem (2927)

Patient Problem Hypoglycemia (1912)

Event Date 12/24/2001

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 called and reported that they received emergency medical assistance due to high blood glucose around (b)(6) 1998 with blood glucose of 700 mg/dl at the time of the incident.The customer was flying to (b)(6) and went through a metal detector.Her pump stopped working while on the flight, and she had to use manual injections and went to the hospital when she landed.The customer used manual injections and was put on intravenous insulin to treat.The customer experienced diabetic ketoacidosis.The customer was wearing the insulin pump during the incident.Troubleshooting was not completed as the pump is no longer available.Customer has been hospitalized 10 times for lows and highs, but can only remember 5 hospitalizations.The insulin pump will not be returned for analysis.

Manufacturer Narrative

The information provided were incorrect with the initial report.The correct information has been provided with this report.

Event Description

Customer called and reported that they received emergency medical assistance due to high blood glucose on (b)(6) 2001 with an unknown blood glucose level.She passed out right after christmas dinner and that is when they found she had gastroparesis.Customer had just eaten a huge carbohydrate filled meal and she bolused and her food didn't catch up with her insulin and the paramedics came.She was given glucagon, then taken to hospital, and was able to come home once her sugars were up.The customer was wearing the insulin pump during the incident.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
• 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: 6854206
• MDR Text Key: 85573612
• Report Number: 2032227-2017-46335
• Device Sequence Number: 1
• Product Code: OYC
• 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: 07/19/2018

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-XXX
• Device Catalogue Number: MMT-XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 09/08/2017
• Supplement Dates Manufacturer Received: 08/14/2017
• Supplement Dates FDA Received: 07/19/2018
• 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 Outcome(s): Hospitalization; Other
• Patient Age: 45 YR
• Patient Weight: 240