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 Premature Discharge of Battery (1057); Device Difficult to Program or Calibrate (1496); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

The customer reported via phone call that the act button of insulin pump was hard to press and battery was not lasting for a week.The customer¿s blood glucose level was unknown at the time of incident.Customer stated that the insulin pump received multiple insulin pump error alarms.Customer was able to clear the alarms and able to complete rewind the insulin pump.Customer stated that the temp basal was not programmed before the unexpected restart alarm occurred and alarm occurred shortly after inserting a new battery.Customer was advised to observe the time clock for one minute and confirmed that time advances.The customer was advised to discontinue use of the insulin pump and revert to the backup plan.Customer was advised that the insulin pump needed to be replaced.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device had intermittent buttons response due to flattened (creased) act buttons dome switch.No unlocked lcd keypad connector noted.Device alarmed a21 after battery change and resets time/date to factory default due to c13 voltage leak at interface board.However, device passed the self-test and displacement test.No unexpected a17 alarm noted during testing.

• 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: 9155044
• MDR Text Key: 163197575
• Report Number: 2032227-2019-73508
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169513099
• UDI-Public: (01)00643169513099
• 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
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 10/17/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2019
• 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 Age: 57 YR
• Patient Weight: 118