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

Model Number MMT_7020A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Component (2292)

Patient Problem Hypoglycemia (1912)

Event Date 01/15/2020

Event Type  Injury  

Event Description

My wife is on medtronic's insulin pump minimed 670g smart guard with guardian sensor.We often rely on the reading of the sensor on how much an insulin dose is given.However we found out that the reading of the sensor on the pump versus the reading of the finger stick is too wide.Sometimes ranging from 70-100 mg/dl.Luckily the pump is not on auto mode.Sometimes my wife will just depend on the sensor reading and take some glucose pill if the reading is 70.Sometimes the sensor will not last for 7 days as advertised.Medtronic, however, is very nice in replacing defective sensors immediately free of charge.We follow their instruction very well.Change the infusion site; change the newly inserted sensor, questioning the use of tylenol, etc.Our endocrinologist has some reservation on the use of these medtronic products now and suggested that sometimes in the future we should switch to another insulin pump.Reason, the hgb a1c of my wife is always above 8.7, in spite of numerous adjustments of the minimed 670g pump by our endocrinologist.I don't have now the data from regular labs but i could remember there was a discrepancy on two results from the quest lab and the minimed 670g pump with cgm.Fda safety report id# (b)(4).

• Brand Name: GUARDIAN SENSOR CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 9728899
• MDR Text Key: 180362392
• Report Number: MW5093077
• Device Sequence Number: 2
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MMT_7020A
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 54