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

Model Number MMT-754DAL

Device Problem Naturally Worn (2988)

Patient Problem Hyperglycemia (1905)

Event Date 05/06/2016

Event Type  malfunction  

Manufacturer Narrative

The insulin pump alarmed for a motor error during the occlusion test due to a faulty force sensor resistor.The insulin pump passed the operating currents, self test, reset error test, displacement test, rewind, basic occlusion test, prime test and excessive no delivery alarm test.No unexpected low battery alarm or low life anomaly was noted.The insulin pump had a worn and stripped battery cap coin slot, a cracked case at the display window corners, cracked battery tube threads, a cracked reservoir tube, a cracked belt clip slot and minor scratches on the display window.The insulin pump involved in this event is the paradigm real-time veo insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.

Event Description

It was reported that the battery cap was worn out and that the battery tube threads were broken.The blood glucose reading was 200 mg/dl.The battery was not lasting as long as it should have been.It was advised that the customer discontinue use of the insulin pump and to revert to a back up plan per a health care professional's instructions.The insulin pump will be replaced and returned for analysis.

• Brand Name: PARADIGM REAL-TIME 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: 5886057
• MDR Text Key: 53063341
• Report Number: 2032227-2016-15756
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P980022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2016

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-754DAL
• Device Catalogue Number: MMT-754DAL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/29/2016
• Initial Date FDA Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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