MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-722LNAS

Device Problem Defective Component (2292)

Patient Problem Hyperglycemia (1905)

Event Date 08/06/2016

Event Type  malfunction  

Manufacturer Narrative

Pump received with blank display due to corroded battery tube spring contact and corroded battery tube.Unable to perform all functional testing including the operating currents, unexpected restart error test, rewind, basic occlusion, occlusion, prime/delivery and excessive no delivery test or verify motor error alarm due to blank display.Motor passed motor test.

Event Description

Customer reported via phone call that the insulin pump had motor error alarms.The customer blood glucose level was 375 mg/dl.The customer was assisted with troubleshooting.Customer states drive support cap appears normal.Customer was able to complete insulin pump rewind.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The device will be returned for analysis.

Manufacturer Narrative

The initial report was submitted with the wrong aware date.The correct date is 8-aug-2019.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAS
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219 ; 8185464805
• MDR Report Key: 8886105
• MDR Text Key: 154147924
• Report Number: 2032227-2019-45561
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00613994409553
• UDI-Public: (01)00613994409553
• 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,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-722LNAS
• Device Catalogue Number: MMT-722LNAS
• Device Lot Number: A000114695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2011
• 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: 36 YR
• Patient Weight: 100