Model Number 1000096 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bruise/Contusion (1754); Hypoglycemia (1912)
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Event Date 11/04/2019 |
Event Type
Injury
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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.
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Event Description
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It was reported that the customer experienced low blood glucose (bg) of 38 mg/dl; cause was unknown.Reportedly, the customer fell and sustained a bruise due to low bg.Paramedics administered glucagon to treat bg level.Additionally, the customer consumed food to treat bg level.Recommendation was made to consult with healthcare provider regarding diabetes management.
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Manufacturer Narrative
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Tandem quality engineer evaluated pump data and concluded the following: an alert 48 (cgm no readings alert) enunciated at 12:17:27 pm on (b)(6) 2019 indicating a temporary sensor failure ¿---" for more than 20 minutes.This issue resulted in no cgm readings again until (b)(6) 2019.Therefore, no cgm readings were observed on (b)(6) 2019.The lowest bg entered into the pump by the user on (b)(6) 2019 was 140 mg/dl.Therefore, the complaint cannot be confirmed.On (b)(6) 2019, user made bolus requests while still having insulin on board (iob).Making bolus requests while still having iob could lead to a low bg event.Allowing the cgm sensor session to be in a ¿---" state prevents the user from continuously monitoring bg and potentially addressing an impending low bg.There is no evidence that the pump experienced a malfunction or failure.
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Search Alerts/Recalls
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