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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM TANDEM G4 INSULIN PUMP
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TANDEM TANDEM G4 INSULIN PUMP Back to Search Results
Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)
Patient Problem No Information (3190)
Event Date 05/27/2016
Event Type  Injury  
Event Description
My insulin pump malfunctioned and stopped working.I have been using a tandem g4 insulin pump since late (b)(6) with no issues until (b)(6).Nothing strange or out of the ordinary happened to cause the malfunction.I gave myself a bolus of about 3 units, and put the pump back in my pocket, a few seconds later the device beeped loudly and the on screen display said, "malfunction" had a phone number to call and a malfunction code - (b)(4).I called the number listed and talked to tandem support.They said the device was not recoverable and new one would be sent.There was no way to reset the device or to determine what had happened.Tandem gave no information.I also had no idea how much, if any, of the bolus i started just before it malfunctioned i had received and i was left not receiving any insulin until i was able to get back to my home.I was okay, but someone in a different situation may have been much worse off.I currently still have the product, but tandem has sent a replacement.I am not using the replacement, opting to use a pump from a different manufacturer.I will have to send back the replacement at some point to avoid being charged.If you want that, you'll have to let me know.
 
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Brand Name
TANDEM G4 INSULIN PUMP
Type of Device
TANDEM G4 INSULIN PUMP
Manufacturer (Section D)
TANDEM
MDR Report Key5732649
MDR Text Key47704572
Report NumberMW5062900
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Age36 YR
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