Model Number 1000096 |
Device Problems
Use of Device Problem (1670); Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.The pump user guide states: warning: never fill your tubing while your infusion set is connected to your body.Always ensure that the infusion set is disconnected from your body before filling the tubing.Failure to disconnect your infusion set from your body before filling the tubing can result in over delivery of insulin.This can cause serious injury or death from very low blood glucose.
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Event Description
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It was reported that the customer received a continuous glucose monitor error.The pump was reset, and the customer continued to use the pump for insulin therapy.It was also reported that the customer inadvertently performed the load fill tubing sequence while connected to the site.The customer's blood glucose level was 151 mg/dl.Tandem technical support educated the customer to not be connected to the pump during the fill tubing process.
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Search Alerts/Recalls
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