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

Model Number MMT-715LWWS

Device Problems Device Displays Incorrect Message (2591); No Flow (2991)

Patient Problem Hyperglycemia (1905)

Event Date 10/27/2016

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.(b)(4).

Event Description

The customer reported via phone call that the insulin pump alarmed no delivery.The customer's blood glucose reading was 260 mg/dl at the time of incident.The customer was advised to prime the device but insulin did not exit the tubing and alarmed no delivery.The customer tried with another reservoir and insulin exited the tubing.Troubleshooting advised that no delivery was most likely the result of an occlusion and changing the reservoir resolved the issue.

Manufacturer Narrative

The insulin pump passed all functional testing including idle current test, run current test, self-test, off no power test, unexpected restart error test, basic occlusion test, occlusion test, prime test, excessive no delivery test, displacement test and rewind test.No excessive no delivery alarm noted.The insulin pump was received with minor scratched display window and cracked reservoir tube lip.

• Brand Name: PARADIGM 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 MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6117498
• MDR Text Key: 60858657
• Report Number: 2032227-2016-43582
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K040676
• 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,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-715LWWS
• Device Catalogue Number: MMT-715LWWS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2016
• 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