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

Model Number MMT-751NAS

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Fall (1848); Hypoglycemia (1912); Injury (2348); Loss of consciousness (2418)

Event Date 04/01/2017

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

Customer reported via phone call of receiving a motor error alarm and no delivery alarm. No delivery alarm was resolved with a complete set change. During troubleshooting for motor error alarm, it was found that insulin pump alarm history contains neither an e70 alarm nor more than one motor error alarm. Customer reported of having low blood glucose and passed out and broke her nose. Customer was taken to the emergency room on (b)(6) 2017 with blood glucose of 31 mg/dl. Customer was treated with iv and was wearing insulin pump at the time of hospitalization.

• 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: 6484176
• MDR Text Key: 72499090
• Report Number: 3004209178-2017-42106
• 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: 04/06/2017

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/11/2017
• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/06/2017
• 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: Unkown

Patient TREATMENT DATA

Date Received: 04/11/2017 Patient Sequence Number: 1