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

Model Number MMT-394T

Device Problems Bent (1059); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 02/03/2018

Event Type  Injury  

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.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 had a high blood glucose level of 434 mg/dl.Customer treated the elevated blood glucose level with a manual injection of insulin.The customer was able to troubleshoot during the call.The customer reported that the infusion set cannula was bent.Customer also reported receiving no delivery alarms.The product 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: 7248692
• MDR Text Key: 99252697
• Report Number: 2032227-2018-01306
• 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: 02/07/2018

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: 07/01/2020
• Device Model Number: MMT-394T
• Device Catalogue Number: MMT-394T
• Device Lot Number: 5173467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 02/07/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 64