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

Model Number MMT-523LNAH

Device Problems Mechanical Problem (1384); Device Displays Incorrect Message (2591); Reset Problem (3019)

Patient Problem Hyperglycemia (1905)

Event Date 06/05/2018

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

The customer reported via phone call that the insulin pump alarmed motor error and compromised force sensor system.Customer's blood glucose level was 41 mg/dl.The customer was able to rewind the insulin pump.Customer was advised to discontinue use of the device and revert to a backup plan.The customer was advised that the device would be replaced and agreed to return the product for analysis.

Manufacturer Narrative

Motor error alarm during the basic occlusion test due to faulty force sensor resistor (gold).The motor was tested outside of the device and passed.Unable to confirm compromised force sensor system alarm due to motor error alarm.Drive support cap was inspected and no anomaly was noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAH
• 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: 7650215
• MDR Text Key: 112720626
• Report Number: 3004209178-2018-86640
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169513839
• UDI-Public: (01)00643169513839
• 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: 07/31/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523LNAH
• Device Catalogue Number: MMT-523LNAH
• Device Lot Number: A4523LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 07/12/2018
• Supplement Dates FDA Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2016
• 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: 41 YR
• Patient Weight: 250