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

Model Number MMT-751NAB

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Fatigue (1849); Hyperglycemia (1905)

Event Date 10/20/2016

Event Type  malfunction  

Manufacturer Narrative

Unit was received with currents in specification.Unit was unable to prime during the prime/compromised force sensor system test due to faulty force sensor resistor.No motor error alarm.Motor passed motor test.Unit had minor scratched lcd window, cracked case near display window corners and broken reservoir tube lip.Drive support disk was inspected and no anomaly was noted.(b)(4).

Event Description

The customer reported via phone call that the insulin pump alarmed motor error.The customer experienced a high blood glucose level of 312 mg/dl.The customer felt tired all day.He treated his blood glucose level with a syringe and insulin pump.The customer was able to rewind the insulin pump.Customer was advised to discontinue use of the device and revert to backup plan.The customer was advised that the device would be replaced and agreed to return the product for analysis.

• 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 MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6121329
• MDR Text Key: 60933828
• Report Number: 2032227-2016-43816
• 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: Patient
• Type of Report: Initial
• Report Date: 11/16/2016

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-751NAB
• Device Catalogue Number: MMT-751NAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 11/22/2016
• 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
• Patient Age: 23 YR
• Patient Weight: 64