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

Model Number MMT-723LNAH

Device Problems Poor Quality Image (1408); Self-Activation or Keying (1557); Device Inoperable (1663)

Patient Problem Hypoglycemia (1912)

Event Date 09/01/2017

Event Type  malfunction  

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 while hospitalized for other health issues with unknown blood glucose values at the time of the incident.The customer reported that their buttons were unresponsive, the numbers were scrolling without input, and the screen was hard to read.The customer was given intravenous fluids to treat.The customer was wearing the insulin pump during the incident.Troubleshooting was completed but did not resolve the issue.The insulin pump will be returned for analysis.

Manufacturer Narrative

The insulin pump was received with no button response due to corroded keypad traces.There was no button error alarm and no numbers scrolling during testing.The device was unable to perform all functional testing including the displacement, operating currents, a 21 error test, rewind, basic occlusion, occlusion, prime test, a 33 test and excessive no delivery test due to buttons not responding.The device was received with minor scratches on the lcd window.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAH
• 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: 7645774
• MDR Text Key: 112585581
• Report Number: 3004209178-2018-86181
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169513884
• UDI-Public: (01)00643169513884
• 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: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723LNAH
• Device Catalogue Number: MMT-723LNAH
• Device Lot Number: A5723LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• 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: 62 YR
• Patient Weight: 253