MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-523LNAL

Device Problems Break (1069); Device Slipped (1584); Naturally Worn (2988)

Patient Problem Hyperglycemia (1905)

Event Date 08/18/2016

Event Type  Injury  

Manufacturer Narrative

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

Customer reported via phone call to have physical damage of insulin pump.Customer reported reservoir compartment thread was worn and was not locking reservoir into place.Customer does not know how damage occurred.Customer's blood glucose was 400 mg/dl.Customer was advised that insulin pump would need to be replaced.

Manufacturer Narrative

The insulin pump functioned properly during functional check including rewind, basic occlusion, occlusion, prime, excessive no delivery, displacement, self-test, a21 test and all operating current measurement were normal.The insulin pump was received with minor scratched display window, cracked case at the display window corners, broken reservoir tube lip, missing the black o ring seal from inside reservoir tube, cracked reservoir tube window, cracked reservoir tube window corners, cracked on the battery tube threads and cracked pump belt clip.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
• Type of Device: INSULIN INFUSION PUMP / SENSOR AUGMENTED
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 5944125
• MDR Text Key: 54502141
• Report Number: 2032227-2016-21010
• 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,Followup
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523LNAL
• Device Catalogue Number: MMT-523LNAL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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 Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 45