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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE TANDEM T:SLIM INSULIN DELIVERY SYSTEM; INSULIN PUMP
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TANDEM DIABETES CARE TANDEM T:SLIM INSULIN DELIVERY SYSTEM; INSULIN PUMP Back to Search Results
Model Number 004628
Medical Device Problem Code False Alarm (1013)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 03/03/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
It was reported that an altitude alarm occurred while the customer was not outside of the labeled operating altitude range.There was no reported impact to the customer's blood glucose level.Reportedly, the customer continued to use the pump for insulin therapy.
 
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Brand Name
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
Common Device Name
INSULIN PUMP
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
MDR Report Key9884202
Report Number3013756811-2020-29057
Device Sequence Number2741136
Product Code LZG
UDI-Device Identifier00852162004590
UDI-Public(01)00852162004590
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K111210
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model Number004628
Device Catalogue Number007445
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/03/2020
Initial Report FDA Received Date03/26/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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