MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-386T QCKSTPRDGM 2PK 9MM32N; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-386T

Device Problem Occlusion Within Device (1423)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 05/26/2018

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 he was hospitalized for an episode of diabetic ketoacidosis.Customer's blood sugar level at the time was over 470 mg/dl.The hospital treated his elevated blood glucose level with an intravenous drip, which lowered his blood sugar levels.Customer was able to troubleshoot during the call.He reported observing air bubbles in the infusion set tubing.Approximate size of air bubbles is 1/4"-3/4".The infusion set and glucose sensor are expected to be returned.

Manufacturer Narrative

The initial report was created in error.

• Brand Name: INFST MMT-386T QCKSTPRDGM 2PK 9MM32N
• 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: 7558077
• MDR Text Key: 109701258
• Report Number: 2032227-2018-04167
• 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,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-386T
• Device Catalogue Number: MMT-386T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization
• Patient Age: 34 YR
• Patient Weight: 127