MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MM T-975T MIO 2PK 9MM 32IN CLEAR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-975T

Device Problem Bent (1059)

Patient Problem Hyperglycemia (1905)

Event Date 09/18/2015

Event Type  Injury  

Manufacturer Narrative

Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on (b)(6) 2014.Subsequently, medtronic diabetes conducted a one 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 hospitalized due to a high blood glucose level.Customer is reporting a past event.Customer reported that her blood glucose level at the time of the hospitalization was over 500 mg/dl.Customer's blood glucose level at the time of the call was 382 mg/dl.Customer reported experiencing a heart attack that caused the hospitalization.Customer reported finding a bent cannula on two infusion sets at the time of the heart attack, elevated blood glucose level, and hospitalization.The product is expected to be returned.

• Brand Name: INFST MM T-975T MIO 2PK 9MM 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: 7131764
• MDR Text Key: 95317441
• Report Number: 2032227-2017-74907
• 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: 12/19/2017

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 Expiration Date: 04/30/2018
• Device Model Number: MMT-975T
• Device Catalogue Number: MMT-975T
• Device Lot Number: 5106192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2015
• Initial Date FDA Received: 12/19/2017
• 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
• Patient Age: 76 YR
• Patient Weight: 64