Model Number 1000096 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypoglycemia (1912); Seizures (2063)
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Event Date 02/19/2019 |
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's blood glucose (bg) was low.Customer consumed glucagon and glucose tablets.Customer had a seizure.Contact transported customer to the emergency room (er).Bg was 52 mg/dl upon arrival to er.Customer's bg/ketone levels were measured and customer was instructed to go the healthcare provider's office.Customer's bg was in the low 200 mg/dl range and customer "was doing better".Contact did not know cause of low bg.As tandem technical support (cts) was not contacted at the time of the event, a cause could not be determined.
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Manufacturer Narrative
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Tandem quality engineer evaluated pump data and concluded the following: blood glucose (bg) of 45 mg/dl was entered into the pump by the user on (b)(6)2019 at (b)(6)am.Immediately following, user requested a 25 unit bolus for a bg of 459 mg/dl.The user likely entered the bg of 45 mg/dl in error.Bg values of 45-52 mg/dl were recorded by continuous glucose monitor (cgm) from (b)(6)am.Cgm alert 3 (cgm glucose reading below user threshold) and cgm alert 1 (cgm low alert) were annunciated.Prior to the low bg, user requested a 10.79 unit bolus for a bg of 251 mg/dl.There were no erratic basal rate adjustments.There were no obvious requests or deliveries that would cause bg levels to drop.There is no evidence that the pump experienced a malfunction or failure.
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Search Alerts/Recalls
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