MAUDE Adverse Event Report: MEDTRONIC MINIMED MINILINK TRANSMITTER; CGM

Model Number MMT-7703NA

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Diabetic Ketoacidosis (2364)

Event Date 01/10/2015

Event Type  Injury  

Event Description

It was reported that the customer's transmitter fell off the customer's skin.Customer had the transmitter taped to their skin.Customer's blood glucose level was 435 mg/dl at the time of the hospitalization.Customer was hospitalized for high blood glucose levels on (b)(6) 2014.Customer had diabetic ketoacidosis.Customer was vomiting and had nausea.Customer treated with the pump and a manual injection.Customer's mother stated that the transmitter falling off the customer did not cause hospitalization.No further assistance needed.

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.Reference manufacturer report number: 2032227-2015-00673.

• Brand Name: MINILINK TRANSMITTER
• Type of Device: CGM
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 121
• Manufacturer Contact: christopher tupper ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764313
• MDR Report Key: 4414808
• MDR Text Key: 5415868
• Report Number: 2032227-2015-01957
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P980022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7703NA
• Device Catalogue Number: MMT-7703NA
• Device Lot Number: A000332456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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: 18 YR
• Patient Weight: 72