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

Model Number MMT-751NAP

Device Problems Break (1069); Crack (1135); Failure to Deliver (2338)

Patient Problems Hyperglycemia (1905); Vomiting (2144); Dizziness (2194); Irritability (2421)

Event Date 11/24/2016

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

A customer reported via phone call indicating that they were hospitalized in (b)(6) of 2016 with a blood glucose level ranging from low 30's to 494 mg/dl.Customer felt irritable, sluggish, vomiting, dizzy, and feels like her brain is a little foggy.The customer was treated for their blood glucose with manual injections and fluids.The customer noticed crack on their insulin pump and experienced a no delivery alarm form the device.The customer stated that they started feeling ill 36 hour prior to the call.The customer stated that they had the flu for 3 days and had been on steroids.The customer was wearing the insulin pump during their hospital stay.Customer stated that there were recent changes to the programing of their insulin pump.The customer was assisted with reviewing the settings on their insulin pump and everything was programed accurately.The customer reports physical damage to the screen of the insulin pump, and as a resulted sent the device back for analysis.

Manufacturer Narrative

The insulin pump passed functional testing including displacement test, rewind, basic occlusion, occlusion, prime and excessive no delivery alarm test.The insulin pump functioned properly.The insulin pump lcd was received with cracked case on display window corners, minor scratched window, cracked reservoir tube lip and scratched around casing.

Manufacturer Narrative

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: 6225717
• MDR Text Key: 64016462
• Report Number: 3004209178-2017-81688
• 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: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAP
• Device Catalogue Number: MMT-751NAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2017
• 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: 28 YR
• Patient Weight: 50