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

Model Number MMT-723LNAS

Device Problems Premature Discharge of Battery (1057); Mechanical Problem (1384); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device received motor error alarm during rewind due to motor encoder signal out of phase.Unable to perform the self-test, pump error alarm, pump alarm, displacement test, rewind, basic occlusion test, occlusion test, prime test and excessive no delivery test due to motor error alarms noted.

Event Description

Customer reported via phone call that insulin pump had multiple error alarms.Customer's blood glucose level was 230 mg/dl at the time of incident.Customer reported they were able to clear the alarm and were able to rewind the insulin pump.Customer reported that the drive support cap was normal.Advised the insulin pump will need to be replaced.Advised to discontinue use of the insulin pump and revert to backup plan.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS
• 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: 9340043
• MDR Text Key: 168950001
• Report Number: 2032227-2019-119473
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169933170
• UDI-Public: (01)00643169933170
• 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
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723LNAS
• Device Catalogue Number: MMT-723LNAS
• Device Lot Number: A6723LNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2018
• 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: 77 YR
• Patient Weight: 107