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

Model Number MMT-751NAH

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hypoglycemia (1912); Overdose (1988); Vomiting (2144)

Event Date 03/15/2015

Event Type  Injury  

Event Description

The customer reported via phone call that the fire department came out to give her glucose.Customer was hospitalized possibly on 03/15/2015.Customer's blood glucose was 12 mg/dl at the time of the incident.Customer stated that it was user error because she was ill with the flu.At the time and had pancreatitis.Customer stated that the pump did suspend and she heard the alarms.Customer stated that the doctor was giving her extra insulin because she was ill and was not eating enough carbs to cover it.Customer had a low blood glucose because she was throwing up and not absorbing the carbs she was eating.Customer declined to troubleshoot.Customer stated that she did a self test and changed everything out including the insulin, site, and battery.

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.

• 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 386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 386
• Manufacturer Contact: christopher tupper ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764313
• MDR Report Key: 4783439
• MDR Text Key: 5876422
• Report Number: 3004209178-2015-57783
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• PMA/PMN Number: P120010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAH
• Device Catalogue Number: MMT-751NAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2015
• 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: 41 YR
• Patient Weight: 59