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

Model Number MMT-723NAP

Device Problems Display or Visual Feedback Problem (1184); Mechanical Problem (1384); Obstruction of Flow (2423); Battery Problem (2885); Power Problem (3010); No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Hypoglycemia (1912); Neuropathy (1983)

Event Date 08/12/2019

Event Type  Injury  

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

The customer reported via phone call that they experienced low blood glucose.The customer¿s current blood glucose level was 42 mg/dl, over 200 mg/dl and 278 mg/dl.Customer stated that they had neuropathy and gastroparesis.Customer stated that insulin pump had just died without alert to a low life.Customer also stated that insulin pump had unspecified pump error and unexplained no delivery alarm.Customer stated that insulin pump had motor error and screen of insulin pump was harder to read in different light.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAP
• 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: 8914807
• MDR Text Key: 155017403
• Report Number: 2032227-2019-50285
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169446465
• UDI-Public: (01)00643169446465
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAP
• Device Catalogue Number: MMT-723NAP
• Device Lot Number: B3723NAPJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2019
• Date Device Manufactured: 07/31/2014
• 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
• Treatment: FRN-UNK-RSVR, UNOMED INF SET
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 154