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

Model Number MMT-751NAS

Device Problems Incorrect Or Inadequate Test Results (2456); High Readings (2459)

Patient Problems Fatigue (1849); Hyperglycemia (1905)

Event Date 01/15/2017

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

A customer reported via phone call indicating that they were hospitalized on (b)(6) 2017 with a blood glucose level of 600 mg/dl due to pneumonia.The customer felt symptoms of vomiting fatigue, and dehydrated.The customer was treated for their blood glucose with their insulin pump.The customer was wearing the insulin pump during their hospital stay.The customer sated that they had a failed battery test.The customer returned the product for analysis.

Manufacturer Narrative

The insulin pump passed functional testing including displacement test, rewind, basic occlusion test, occlusion test, prime test and excessive no delivery test.The insulin pump was received with normal operating currents and no unexpected off no power alarm, low battery alarm or failed battery alarm noted.The insulin pump passed the displacement accuracy test.The insulin pump had cracked case at the display window corner, minor scratched lcd window, cracked battery tube threads and cracked reservoir tube lip.

• 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: 6297210
• MDR Text Key: 66398298
• Report Number: 3004209178-2017-88624
• 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,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/10/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2017
• 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): Other
• Patient Age: 65 YR
• Patient Weight: 73