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

Model Number MMT-751NAP

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Unspecified Infection (1930); No Code Available (3191)

Event Date 08/22/2016

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.(b)(4).

Event Description

The customer reported via phone call that she was in the hospital for nearly four weeks due to her diabetes; her blood glucose had been high due to losing her insulin pump settings.The patient's blood glucose at the time of hospital admission was in the high 400 mg/dl range.The patient experienced fever, delirium, and foot infection.The patient had an amputation on her foot and was kept in the hospital for rehabilitation.The insulin pump alarmed battery out limit and the customer was advised that this was normal since she had stored the insulin pump without its battery for the duration of her hospital stay.During troubleshooting, it was discovered that the insulin pump settings were still present.The customer was assisted with clearing the battery out limit alarm and reprogramming the time and date.It was confirmed that the basal rates were still present.No products were returned or replaced.

• 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: 6000585
• MDR Text Key: 56496525
• Report Number: 2032227-2016-27959
• 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: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 55 YR
• Patient Weight: 70