MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-723NAB

Device Problems No Display/Image (1183); Naturally Worn (2988)

Patient Problem Hyperglycemia (1905)

Event Date 10/11/2013

Event Type  malfunction  

Manufacturer Narrative

The insulin pump was monitored and no blank display was noted.No anomaly was found on the battery tube assembly or electronic board.The pump had cracked reservoir tube and lip, broken battery tube threads and scratched display window and missing end cap sticker.This is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on july 1, 2014.Subsequently, medtronic diabetes conducted a one year retrospective review of complaints.This event was retrospectively identified to be reportable based on the revised mdr reportability criteria.

Event Description

The customer reported via phone call of a blank display and damage from the insulin pump.The customer's blood glucose level was 299 mg/dl.The customer stated that the display was blank and when he changed the battery, it would not turn back on.The customer reported damage on the battery cap.The customer stated that the battery cap was worn down and he had to use pliers and screwdriver to remove it.The customer was advised to discontinue use of the device and revert to a backup plan per health care provider's instructions.The customer will be sent a replacement pump.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
• Type of Device: INSULIN INFUSION PUMP / SENSOR AUGMENTED
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 5949677
• MDR Text Key: 55022488
• Report Number: 3004209178-2016-77099
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• PMA/PMN Number: P980022
• 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: 10/11/2013

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-723NAB
• Device Catalogue Number: MMT-723NAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2013
• Initial Date FDA Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 18 YR
• Patient Weight: 61