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

Model Number MMT-723RNAB

Device Problems Crack (1135); Device Inoperable (1663); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2017

Event Type  malfunction  

Manufacturer Narrative

The pump was received with cracked and bleeding lcd glass, minor scratched lcd window, cracked case at the display window corners, cracked lcd window, cracked belt clip slot, stained end cap sticker, stained address/serial number label and cracked reservoir tube lip.

Event Description

The customer reported via phone call that the insulin pump was not working and there was crack and scratches on lcd screen.The customer¿s blood glucose level was 150 mg/dl.The customer also reported that customer was not able to seethe screen because it was almost completely black and faded.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAB
• 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: 7445092
• MDR Text Key: 106022993
• Report Number: 3004209178-2018-66272
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169513105
• UDI-Public: (01)00643169513105
• 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
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723RNAB
• Device Catalogue Number: MMT-723RNAB
• Device Lot Number: A1723RNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/19/2018
• 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: 17 YR
• Patient Weight: 130