MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-723NAP

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Respiratory Distress (2045); Diabetic Ketoacidosis (2364)

Event Date 01/30/2017

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.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 they were hospitalized for diabetic ketoacidosis on (b)(6) 2017 with a blood glucose level of blood glucose of 440 mg/dl.The customer experienced symptoms such as shortness of breath.The customer was treated at the hospital but did not provide the nature of the treatment.The customer was wearing the insulin pump during the hospitalization.The insulin pump will be returned for analysis.

Manufacturer Narrative

The insulin pump received with the operating currents within spec.And passed the self-test, unexpected restart error test, rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test, displacement test, and the displacement accuracy test.The insulin pump was programmed with multiple boluses and monitored.All boluses delivered properly and were listed in the bolus history screen.The insulin pump then was programmed with multiple basal profiles and monitored.All basal profiles delivered their indicated amounts and were verified in the daily total screen.The units left at pump display matched properly the units left at test reservoir.No delivery anomaly, bolus anomaly or basal anomaly noted during testing.No cosmetic damage noted during physical inspection.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
• Type of Device: INSULIN INFUSION PUMP / SENSOR AUGMENTED
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6426584
• MDR Text Key: 70627141
• Report Number: 3004209178-2017-97286
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• PMA/PMN Number: P980022
• 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: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAP
• Device Catalogue Number: MMT-723NAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 18 YR