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

Model Number MMT-7703NA

Device Problems Device Inoperable (1663); High Readings (2459); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2017

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

The customer reported via phone call that they were hospitalized due to high blood glucose over 800 mg/dl.The customer reported 16 days ago when he was brought to hospital.Unable to troubleshoot and pump is not working.The insulin pump will be returned for analysis.

Manufacturer Narrative

Insulin pump had failed led testing and unable to charge due to battery depleted (battery voltage 0 volt).Unable to perform the functional testing due to charge anomaly.

Manufacturer Narrative

Event was reported in error.

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: 6887294
• MDR Text Key: 87183884
• Report Number: 2032227-2017-51647
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/16/2020

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-7703NA
• Device Catalogue Number: MMT-7703NA
• Device Lot Number: A000220482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2017
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 09/22/2017
• Supplement Dates Manufacturer Received: 10/24/2017; 10/24/2017; 04/16/2020
• Supplement Dates FDA Received: 10/30/2017; 04/15/2020; 04/16/2020
• 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): Hospitalization; Other
• Patient Age: 61 YR
• Patient Weight: 144