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

Model Number MMT-751NAS

Device Problem Insufficient Information (3190)

Patient Problems Hypoglycemia (1912); Overdose (1988); Seizures (2063); Loss of consciousness (2418)

Event Date 02/27/2015

Event Type  Injury  

Event Description

Customer reported via phone, customer had experienced a seizure due to low blood glucose.Customer stated the insulin pump was alarming and his family found him unconscious.Customer stated he knew he was low but instead of eating something in the streets decided to eat healthy at home.Customer made it home and was found passed out.Customer's mother gave him glucagon but it didn't work, paramedics took him to the hospital.Customer's blood glucose at the time of admission was 32 or 35 mg/dl.Customer stated the perceived cause was he ate and overdosed, then the insulin pump administered a basal in between and it doubled the insulin.Customer stated he was aware he was going low but he didn't treat appropriately.Customer was advised to call when issue occurred to properly troubleshoot the device.Customer is not returning the device for further analysis.

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: 4801316
• MDR Text Key: 5926100
• Report Number: 3004209178-2015-59820
• 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: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAS
• Device Catalogue Number: MMT-751NAS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2015
• 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: 22 YR
• Patient Weight: 64