MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-965T MIO 2PK 6MM 32IN CLEAR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-965T

Device Problem Bent (1059)

Patient Problem Hyperglycemia (1905)

Event Date 07/04/2017

Event Type  Injury  

Manufacturer Narrative

Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on (b)(6).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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

Customer reported via phone call that they experienced elevated blood glucose along with accompanying symptoms.The symptoms that they reported were nausea and abdominal pains.Customer reported calling an after hours nurse for assistance with treating elevated blood glucose.Customer treated with 2 units of novalog.Customer reported that the infusion set cannula was bent in the shape of a check mark.Customer's current blood glucose is 245 mg/dl.Customer's blood glucose at the time of the incident was 187 mg/dl.The product is expected to be returned.

• Brand Name: INFST MMT-965T MIO 2PK 6MM 32IN CLEAR
• 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: 6982060
• MDR Text Key: 90387635
• Report Number: 2032227-2017-62065
• 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: 10/26/2017

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-965T
• Device Catalogue Number: MMT-965T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2017
• Initial Date FDA Received: 10/26/2017
• 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: 30 YR