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 Dehydration (1807); Hyperglycemia (1905); Urinary Frequency (2275); Alteration In Body Temperature (2682)

Event Date 11/26/2016

Event Type  Injury  

Manufacturer Narrative

Pump received with no button response due to flattened all button dome switch.No unlocked lcd keypad connector.Unable to perform all functional testing including the displacement, operating currents, unexpected restart error test, rewind, basic occlusion, occlusion, prime/delivery and excessive no delivery test or verify history anomaly and excessive no delivery alarm due to buttons not responding.Pump received with cracked case at the display window corner, cracked reservoir tube lip, minor scratched lcd window and cracked battery tube threads.(b)(4).

Event Description

It was reported via phone call that customer received no delivery alarm.Customer's blood glucose was 527 mg/dl.Customer reported that high blood glucose began on (b)(6) 2016.Customer did not go to the hospital and did not contact healthcare professional.Customer had symptoms of high blood glucose; customer had dry mouth, excessive urination, and feeling hot.Troubleshooting was performed on insulin pump to determine reason for high blood glucose.Customer reported that drive support cap appeared normal.Customer states there were no leaks or air bubbles; there were no site or insulin issues; and settings were correct.Insulin pump passed high pressure test.Insulin pump would be replaced and customer believed that insulin pump was not working.

• 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: 6203230
• MDR Text Key: 63265480
• Report Number: 2032227-2016-52922
• 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: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2016
• 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: 12/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2016
• 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 Outcome(s): Other
• Patient Age: 23 YR
• Patient Weight: 50