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

Model Number MMT-751NAB

Device Problems Break (1069); Scratched Material (3020)

Patient Problems Syncope (1610); Hypoglycemia (1912)

Event Date 02/13/2017

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

Customer's spouse reported via phone call that the customer experienced low blood glucose readings and was taken to the emergency room as the customer passed out.Customer's blood glucose readings at the time of the hospitalization is unknown.Furthermore customers spouse stated that the insulin pump was scratched and has to use a magnifying glass to view the screen.It was noted that the damage occurred during daily work activities and the customer is unable to read the screen of the insulin pump.

Manufacturer Narrative

The pump passed the functional tests, including the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery tests.The pump was received with normal operating currents and no unexpected off no power alarm or low battery alarms noted.The pump passed the delivery accuracy test.The pump was received with minor scratches on the lcd window, a cracked case at the display window corner and a 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: 6362931
• MDR Text Key: 68468650
• Report Number: 3004209178-2017-93195
• 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: other
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

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-751NAB
• Device Catalogue Number: MMT-751NAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 02/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2017
• 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): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 100