T:SLIM X2 INSULIN PUMP 1000096 1000103

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for T:SLIM X2 INSULIN PUMP 1000096 1000103 manufactured by Tandem Diabetes Care.

Event Text Entries

[187265836] The device has been received for evaluation; however, device evaluation is not yet complete. A supplemental report will be filed upon completion of the evaluation.
Patient Sequence No: 1, Text Type: N, H10

[187265837] It was reported that the pump could not be intermittently charged properly without the customer maneuvering the cable into the charging port due to damage to the charging port. Subsequently, it was reported that the pump battery could not be charged. Customer's blood glucose reached 291 mg/dl. The customer continued to use the pump for insulin therapy.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number3013756811-2020-30319
MDR Report Key9908404
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-08
Date Mfgr Received2020-03-10
Device Manufacturer Date2016-11-01
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMICK TRIER
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8584011451
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeLZG
Date Received2020-03-31
Returned To Mfg2020-03-25
Model Number1000096
Catalog Number1000103
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
Manufacturer Address11075 ROSELLE STREET SAN DIEGO CA 92121 US 92121


Patient NumberTreatmentOutcomeDate
10 2020-03-31

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