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U.S. Department of Health and Human Services

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

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TANDEM / UNOMEDICAL A/S TANDEM T SLIM INSULIN PUMP / INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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).
 
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Brand NameTANDEM T SLIM INSULIN PUMP / INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
TANDEM / UNOMEDICAL A/S
MDR Report Key12569507
MDR Text Key274793495
Report NumberMW5104357
Device Sequence Number1
Product Code FPA
Reporter Country CodeUS
Number of Events Reported1
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 Received10/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAUTO SOFT 90 INFUSION SET 60CM
Device Catalogue Number1002817
Device Lot Number5349711
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
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