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

Model Number MMT-751NAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); Injury (2348)

Event Date 07/06/2016

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.

Event Description

The customer reported via phone call that she was recently hospitalized with two broken legs and with insulin issues.The customer broke her first leg on (b)(6) 2016 due to a low blood glucose level.Her father called the ambulance.Her blood glucose level was 24 mg/dl when the ambulance arrived and was taken to the hospital.She may have tripped on a rug and broke her second leg in the beginning of (b)(6).She was admitted into the hospital again but this time it was non-diabetes related.The customer was given packets to treat her low blood glucose level.She was wearing the insulin pump at the time of hospitalization.The second time she was hospitalized she was off the insulin pump for less than 48 hours.The device was not returned.

• 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: 6086774
• MDR Text Key: 59418949
• Report Number: 2032227-2016-40663
• 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: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAL
• Device Catalogue Number: MMT-751NAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2016
• 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: 57 YR
• Patient Weight: 82