MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP; OZO

Model Number MMT-751NAS

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Deliver (2338); Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Overdose (1988)

Event Date 02/19/2016

Event Type  Injury  

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

The customer reported via phone call that he had a motor error and a no delivery alarm on the insulin pump.Customer's blood glucose was 150 mg/dl at the time of the incident.Customer stated that he had called an emergency medical technician this week because he had given himself too much insulin and was not eating enough.Customer also stated that there wasn't any serious injury or hospitalization.Customer did not report a motor position encoder error alarm.Customer was assisted in performing pump rewind but it stopped at no delivery and a motor error occurred.The customer was advised to discontinue use of the pump and to revert to a back-up plan.Customer was also advised that the insulin pump will need to be replaced.

Manufacturer Narrative

The insulin pump was received with all operating currents within specifications and passed functional testing including the rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test.No motor error alarms noted.However, the insulin pump had cracked case at the display window corners and minor scratched lcd window.

Manufacturer Narrative

Additional information has been provided by failure analysis that was not included on the initial device evaluation: the motor was tested outside the device and passed.The insulin pump passed the displacement accuracy test.

• Brand Name: 530G INSULIN PUMP
• Type of Device: OZO
• 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: 5475350
• MDR Text Key: 39523290
• Report Number: 3004209178-2016-90182
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• PMA/PMN Number: 120010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAS
• Device Catalogue Number: MMT-751NAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 98