MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-523LNAS

Device Problems Sticking (1597); Device Inoperable (1663); Device Displays Incorrect Message (2591); Naturally Worn (2988); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2017

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

A nurse reported via phone call that the insulin pump had damage and a keypad anomaly.Troubleshooting for button error/keypad anomaly was performed.Customer's blood glucose level was unknown at the time of the incident.The reporter stated that the buttons were sticking.The reporter also stated that there was no significant event leading to the keypad issues and that the time on the clock advanced when monitored for one minute.Troubleshooting for damage was performed as the reporter stated that the screen was so scratched that parts were hard to read.The reporter stated that the damage occurred due to wear and tear.Per both troubleshooting, the reporter was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump will be returned for analysis.

Manufacturer Narrative

Findings: unit had intermittent buttons response due to flattened (creased) act and up buttons dome switch.No unlocked lcd keypad connector noted.Unit had severely scratched lcd window, cracked battery tube threads, cracked reservoir tube lip, scratched reservoir tube window, stained address/serial number label and stained end cap sticker.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAS
• 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: 6815641
• MDR Text Key: 83624557
• Report Number: 2032227-2017-40108
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169513860
• UDI-Public: (01)00643169513860
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523LNAS
• Device Catalogue Number: MMT-523LNAS
• Device Lot Number: A4523LNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 40 YR
• Patient Weight: 216