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

Model Number MMT-722NAS

Device Problems Battery Problem (2885); Device Dislodged or Dislocated (2923)

Patient Problem Hyperglycemia (1905)

Event Date 07/18/2016

Event Type  malfunction  

Manufacturer Narrative

The insulin pump was received with a blank display due to a missing battery tube spring.They were unable to perform the displacement test due to a blank display.The pump was received with a cracked reservoir tube lip, a minor scratched display window, a cracked belt clip slot, cracked battery tube threads, a scratched reservoir tube window, and a corroded battery tube.

Event Description

The customer reported via phone call that he was changing the battery in the insulin pump and a small spring at the base of the battery fell out.Customer stated that the pump started beeping low battery.Customer opened the battery compartment to take the battery out and the spring came out from the battery compartment.Customer's blood glucose was 150 mg/dl.Customer was advised that the pump will need to be replaced.Customer was advised to discontinue use of the pump and revert to a back-up plan.

• Brand Name: PARADIGM REAL-TIME 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: 5889206
• MDR Text Key: 53399809
• Report Number: 3004209178-2016-70152
• 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: Other
• Type of Report: Initial
• Report Date: 08/03/2016

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-722NAS
• Device Catalogue Number: MMT-722NAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2016
• Initial Date FDA Received: 08/19/2016
• 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: 44 YR