MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR MMT-7020C1 GS3 5PK 2L CANADA; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7020C1

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 02/06/2019

Event Type  malfunction  

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

It was reported that the needle did not came out after sensor insertion.The customer¿s blood glucose level was unknown at the time of the incident.The insulin pump will not be returned for analysis.

Manufacturer Narrative

The information provided in section date of event with the initial report was incorrect.The correct information has been included with this report.

Event Description

Updated to no consequence for the harm as no indication that needle broke, and no medical assistance needed and needle did not remain in customer's body.

• Brand Name: SENSOR MMT-7020C1 GS3 5PK 2L CANADA
• 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 ; 8185464805
• MDR Report Key: 8346642
• MDR Text Key: 136461650
• Report Number: 2032227-2019-01518
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7020C1
• Device Catalogue Number: MMT-7020C1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1