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

Model Number MMT-523RNAS

Device Problems Component Falling (1105); Device Operates Differently Than Expected (2913)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 05/20/2018

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

Customer reported via phone call low blood glucose.The customer's blood glucose was 28mg/dl at the time of incident.Trouble shooting was performed device fell out of holster and since has been experiencing low blood glucose.Customer treated low with glucose tablets.Customer is unable to upload to carelink at this time.Advice to complete carelink upload before device return if possible and to call for assistance with upload if needed.No issue was determined advised the insulin pump will need to be replaced.Advice to discontinue use of the insulin pump and revert to backup plan.The insulin pump will be returned for analysis.

Manufacturer Narrative

Unit received with all operating currents within specification and passed functional testing including the rewind test, self-test, unexpected restart error test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test.Also, unit passed the delivery accuracy test.No possible over/under delivery anomaly noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS
• 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 ; 8185464805
• MDR Report Key: 7655857
• MDR Text Key: 112932568
• Report Number: 3004209178-2018-86879
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169513099
• UDI-Public: (01)00643169513099
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523RNAS
• Device Catalogue Number: MMT-523RNAS
• Device Lot Number: A1523RNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 136