Model Number 1000096 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypoglycemia (1912); Concussion (2192)
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Event Date 07/31/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received.
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Event Description
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It was reported that the customer experienced a low blood glucose (bg) of 20 mg/dl; cause was unknown.Reportedly, the customer had a concussion from falling.The customer iced head and was okay and did not receive medical treatment for the concussion.The paramedics gave the customer glucose gel.The customer was not taken to the emergency room or hospital and reported "feeling better".
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Manufacturer Narrative
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Tandem quality engineer evaluated pump data and concluded the following: blood glucose (bg) was not entered into the pump by the user on (b)(6)2019 and continuous glucose monitor (cgm) was not in use.There were no erratic basal rate adjustments.User made bolus requests without entering current bg.Making bolus requests while still having iob could lead to a low bg event.There is no evidence that the pump experienced a malfunction or failure.
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Search Alerts/Recalls
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