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

Model Number MMT-551NAH

Device Problem Bent (1059)

Patient Problems Dysphagia/ Odynophagia (1815); Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Diabetic Ketoacidosis (2364); Ambulation Difficulties (2544); Cognitive Changes (2551)

Event Date 04/10/2016

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 indicating that she was hospitalized due to high blood glucose.Customer's blood glucose at time of incidents was 390 mg/dl.The customer was experiencing symptoms of dehydration, couldn't walk, talk or think straight, nausea and vomiting.The customer was treated with the pump.The customer was explained the 2 high blood glucose rule.The customer was admitted to the hospital.Customer's blood glucose at time of emergency room visit was 390 mg/dl.The customer cause of emergency room visit was diabetic ketoacidosis.Customer was still in the hospital they will not release her until they know the pump is working.The customer was wearing the pump at the time of emergency room visit.Customer had a bent cannula and stated it appeared to not have been inserted in her skin.Customer declined to continue troubleshooting.

• 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 PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 5621945
• MDR Text Key: 44134843
• Report Number: 3004209178-2016-43836
• 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: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAH
• Device Catalogue Number: MMT-551NAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2016
• 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: 47 YR
• Patient Weight: 82