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

Model Number MMT-751NAS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Bone Fracture(s) (1870); Hyperglycemia (1905); Hypoglycemia (1912); Overdose (1988); Seizures (2063)

Event Date 07/07/2014

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 that she was hospitalized on (b)(6) 2014.The customer stated that after dinner she was not feeling well and told her husband.Her blood glucose was low and she had a seizure and broke her ankles.The customer went through 4 surgeries.Blood glucose value was 17 mg/dl.The customer stated she has been experiencing low blood glucose for 2 years and was taking medication for irregular heartbeat.The drive support cap is normal.The customer was disconnected during the rewind/prime sequence.The reservoir was showing the same amount of insulin as shown on the status screen.Device was not exposed to a magnetic field and passed the displacement test.The customer stated she over bloused to treat high blood glucose.She also reported she was pushed into the pool with the insulin pump.Current blood glucose is 196 mg/dl.

• 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: 5016616
• MDR Text Key: 23515945
• Report Number: 2032227-2015-31904
• 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: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAS
• Device Catalogue Number: MMT-751NAS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2015
• 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: 60 YR
• Patient Weight: 59