MAUDE Adverse Event Report: MEDTRONIC MINIMED OTHER; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-XXX

Device Problem High Test Results (2457)

Patient Problem Hyperglycemia (1905)

Event Date 06/28/2017

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 experiencing high blood glucose of 592 mg/dl and was lowered to 338 after treating with manual injection.Customer's high blood glucose event began on (b)(6) 2017.Troubleshooting was performed and insulin pump passed the high pressure test.Customer was advised to follow-up with healthcare professional and that infusion set would be replaced due to early removal for testing.Customer also reported a past hospitalization event with a different insulin pump.Customer was hospitalized due to high blood glucose.Customer does not remember date of hospitalization.Customer's blood glucose reading at the time of hospitalization was 750 mg/dl.Prior to hospitalization, customer reported of not feeling well and was feeling nauseous.Customer's blood glucose was 592 mg/dl the customer was treated with manual injection.The customer was wearing the insulin pump during the hospitalization.The insulin pump was already returned as incident occurred a few years prior.

• Brand Name: OTHER
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 6740864
• MDR Text Key: 80936810
• Report Number: 2032227-2017-31127
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-XXX
• Device Catalogue Number: MMT-XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/25/2017
• 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 Age: 75 YR
• Patient Weight: 180