MAUDE Adverse Event Report: TANDEM / UNOMEDICAL A/S TANDEM T SLIM INSULIN PUMP / INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

Model Number AUTO SOFT 90 INFUSION SET 60CM

Device Problems Loss of or Failure to Bond (1068); Failure to Infuse (2340); Connection Problem (2900)

Patient Problem Hyperglycemia (1905)

Event Date 09/30/2021

Event Type  Injury  

Event Description

Infusion set tube wasn't bonded to end inserter which didn't allow insulin to be administered resulting in severe hyperglycemia during sleep. Fda safety report id # (b)(4).

• Brand Name: TANDEM T SLIM INSULIN PUMP / INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): TANDEM / UNOMEDICAL A/S
• MDR Report Key: 12569507
• MDR Text Key: 274793495
• Report Number: MW5104357
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: AUTO SOFT 90 INFUSION SET 60CM
• Device Catalogue Number: 1002817
• Device Lot Number: 5349711
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 10/01/2021 Patient Sequence Number: 1