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

Model Number MMT-723LNAL

Device Problems Mechanical Problem (1384); Device Difficult to Program or Calibrate (1496); Difficult or Delayed Activation (2577); Power Problem (3010)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2018

Event Type  malfunction  

Manufacturer Narrative

Insulin pump was received with intermittent button response due to flattened dome switch on esc and act button.Connector was inspected and locked on lcd board.No button error alarm and frozen screen noted during testing.Insulin pump passed displacement test, rewind test, basic occlusion test, prime/compromised force sensor system test, excessive no delivery test and occlusion test.No rewind anomaly noted.Insulin pump passed self test, unexpected restart error test, off no power test and all operating currents tested within the spec range.Insulin pump was monitored and tested with no failed battery test and blank display noted.

Event Description

The customer reported via phone call that the insulin pump had keypad anomaly.The customer¿s blood glucose level was unknown.The customer reported that the press the button, hold act to fill tubing and nothing happens.It was reported that the insulin pump rejected a brand new battery.It was reported that the battery may fail test if it has potential to cause insulin pump to lose power without warning.The customer was advised if not aligned or tightened the insulin pump may alarm failed battery test.Customer did not receive failed battery test.The customer was advised to monitor the insulin pump.The customer was advised we will ship a replacement battery cap as a courtesy to rule out any possible issues with the battery cap.The insulin pump will be returned for analysis.

Manufacturer Narrative

The information provided in additional mfr narrative was incorrect with the initial report.The correct information has been provided with this report.Insulin pump was received with intermittent button response due to flattened dome switch on esc and act button.Connector was inspected and locked on lcd board.No button error alarm and frozen screen noted during testing.Insulin pump passed displacement test, rewind test, basic occlusion test, prime/compromised force sensor system test, excessive no delivery test and occlusion test.No rewind anomaly noted.Insulin pump passed self test, unexpected restart error test, off no power test and all operating currents tested within the spec range.Insulin pump was monitored and tested with no failed battery test and blank display noted.The asr exemption e2015043 was revoked on february 4, 2019.This event was previously reported as an asr.Additional information or analysis results regarding this event will be reported as an mdr.

Manufacturer Narrative

The supplemental report had the incorrect aware date.The correct aware date is 07-feb-2019.

Manufacturer Narrative

The date provided with the initial report was incorrect.The correct date is february 7, 2019.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL
• 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: 8343937
• MDR Text Key: 136601097
• Report Number: 3004209178-2019-56318
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169933156
• UDI-Public: (01)00643169933156
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723LNAL
• Device Catalogue Number: MMT-723LNAL
• Device Lot Number: A6723LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2018
• 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 Age: 67 YR
• Patient Weight: 270