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

Model Number MMT-551NAP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hypoglycemia (1912); Overdose (1988)

Event Date 07/18/2015

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

Customer reported via phone call to have taken too much insulin which resulted in blood glucose of 22 mg/dl.Paramedics were called and customer was treated with glucagon.Customer reported of having problems with sensor taping and was educated on proper taping procedure.

• 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: 5008957
• MDR Text Key: 23216896
• Report Number: 2032227-2015-30542
• 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
• Report Date: 07/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAP
• Device Catalogue Number: MMT-551NAP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2015
• 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): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 86