MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-943T MIO 2PK 6MM 23IN BLUE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-943T

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2017

Event Type  Injury  

Manufacturer Narrative

This is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on (b)(6) 2017.Subsequently, medtronic diabetes conducted a two year retrospective review of complaints.This event was retrospectively identified to be reportable based on the revised mdr reportability criteria.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

Customer reported via phone call that they were experiencing high blood glucose.Customer reported that blood glucose at time of incident was 248 mg/dl.Customer reported that they changed the infusion set at 9 am and discontinued use at 2:45 pm on the same day.Customer reports that they began to feel bad physically as a symptom of the elevated blood glucose.Customer states as blood glucose rose and she began to feel symptoms, she removed the infusion set and noticed a bent cannula.Product is expected to be returned.

• Brand Name: INFST MMT-943T MIO 2PK 6MM 23IN BLUE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 6978410
• MDR Text Key: 90280378
• Report Number: 2032227-2017-61612
• Device Sequence Number: 1
• Product Code: FPA
• 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
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-943T
• Device Catalogue Number: MMT-943T
• Device Lot Number: 5157432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2017
• 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: 35 YR