MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-394T QCKSTPRDGM 2PK 6MM18N; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-394T

Device Problems Failure To Adhere Or Bond (1031); Bent (1059); Component Falling (1105)

Patient Problem Hyperglycemia (1905)

Event Date 12/09/2016

Event Type  Injury  

Manufacturer Narrative

Note: 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's mother reported via phone call that they experienced a high blood glucose level.Customer's mother reported that the customer's blood glucose level was reported as being 400 mg/dl at the time of the incident.Customer's mother reported that her daughter's blood glucose level at the time of the call was 379 mg/dl.Customer's mother reported that she treated her daughter's elevated blood glucose level with a manual injection of insulin.Customer's mother reported that they last changed their infusion set earlier in the day of the call.Customer's mother was able to troubleshoot during the call.Customer's mother also reported an infusion set falling off.Customer's mother declined troubleshooting for the adhering anomaly.Customer's mother reported that the upon removal of the infusion set that was in use during the elevated blood glucose incident, she found that the infusion set cannula was bent like a big curved knitting needle.The infusion set is expected to be returned.

• Brand Name: INFST MMT-394T QCKSTPRDGM 2PK 6MM18N
• 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: 7151408
• MDR Text Key: 95938782
• Report Number: 2032227-2017-77751
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20613994761754
• UDI-Public: (01)20613994761754(017)20170701
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2017
• Device Model Number: MMT-394T
• Device Catalogue Number: MMT-394T
• Device Lot Number: 002979807T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2016
• Date Device Manufactured: 08/09/2016
• 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): Other
• Patient Age: 3 YR
• Patient Weight: 18