MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-723RNAS

Device Problems Fluid/Blood Leak (1250); Inaccurate Delivery (2339)

Patient Problem Hypoglycemia (1912)

Event Date 05/30/2018

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Customer called and reported that they experienced low blood glucose on (b)(6) 2018 with blood glucose of 52 mg/dl at the time of the incident.The customer used glucose tablets to treat.The customer was wearing the insulin pump during the incident.Customer states the pump was over delivering.Troubleshooting was completed but did not resolve the issue.The customer notices that after the reservoir is locked in, the quick set will squirt out insulin.The customer has lost 12 pounds and exposed the pump to x rays.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device received with no (act and escape) button response due to flattened button dome switch (no crease).The keypad connector on lcd is locked properly during visual inspection.Unable to verify exposure to magnetic field, possible over delivery anomaly and perform all functional tests, including the idle current measurement test, run current measurement test, self test, off no power test, unexpected restart error test, displacement test, basic occlusion test, occlusion test, prime test, rewind test, excessive no delivery test and displacement accuracy test due to no button response.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS
• 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: 7613325
• MDR Text Key: 111452867
• Report Number: 3004209178-2018-83088
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169513143
• UDI-Public: (01)00643169513143
• 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: 02/19/2019

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-723RNAS
• Device Catalogue Number: MMT-723RNAS
• Device Lot Number: A1723RNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 02/18/2019
• Supplement Dates FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2016
• 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: MMT-332A; MMT-397
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR
• Patient Weight: 225