Model Number 1000096 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Hypoglycemia (1912)
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Event Date 02/19/2020 |
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 a low blood glucose (bg) level of approximately 20 mg/dl after the health care provided adjusted the pump settings.Reportedly, customer fell and broke their foot as a result of the low bg.Customer consumed carbohydrates to address low bg.Recommendation was made to discuss diabetes management with a health care professional.
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Manufacturer Narrative
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Remove "other serious"; add "hospitalization" and "required intervention" additional information was received reporting that the customer was hospitalized on (b)(6)2020 due to a low blood glucose level of 22 mg/dl.Customer did not recall treatment received while hospitalized, however, suspected glucose and an intravenous drip was administered for treatment.Customer was released from the hospital on (b)(6)2020.
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Search Alerts/Recalls
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