MAUDE Adverse Event Report: MEDTRONIC MINIMED MINILINK TRANSMITTER MMT-7703NA; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7703NA

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Date 08/13/2017

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

The customer called to report a low blood glucose level of 47 mg/dl.The customer treated the low blood glucose level with juice.The customer stated the blood glucose level is now 60 mg/dl.The customer declined to troubleshoot for the low blood glucose level.The product will not be returned for analysis.

Manufacturer Narrative

Event was reported in error.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.

Manufacturer Narrative

The follow up report was submitted with blank.The correct date is 15-apr-2020.

• Brand Name: MINILINK TRANSMITTER MMT-7703NA
• 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: 6839787
• MDR Text Key: 84612710
• Report Number: 2032227-2017-44073
• 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,Followup,Followup
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• 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: A000341647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2020
• 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): Other
• Patient Age: 55 YR
• Patient Weight: 165