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

Model Number MMT-722RNAP

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

Event Type  malfunction  

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

Event Description

Customer reported via phone call that insulin pump had comprised force sensor system alarm.The customer¿s blood glucose level was unknown.Customer state that the insulin was squirting out during manual prime process.The drive support cap normal.The insulin pump will not be returned for analysis.

Manufacturer Narrative

Device passed the displacement test.Device received with motor error alarm during the basic occlusion test due to loose or protruded drive support disk.Unable to perform prime test, excessive no delivery test and occlusion test or verify prime or fill anomalies and compromised force sensor system alarm due to motor error alarm.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAP
• 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
• MDR Report Key: 7594947
• MDR Text Key: 111154112
• Report Number: 2032227-2018-05366
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00613994623928
• UDI-Public: (01)00613994623928
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-722RNAP
• Device Catalogue Number: MMT-722RNAP
• Device Lot Number: A000142628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2009
• 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: 42 YR
• Patient Weight: 220