Model Number 71992-01 |
Device Problem
Low Readings (2460)
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Patient Problems
Hyperglycemia (1905); Nausea (1970); Chills (2191)
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Event Date 12/13/2022 |
Event Type
Injury
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Event Description
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A low reading issue was reported with the adc device.The customer obtained a reading of 52 mg/dl and experienced symptoms of nausea, short breath, chills, and presented to the emergency room.The customer had a cbc, urinalysis, chest x-ray, and heart ultrasound performed.The customer was diagnosed with hyperglycemia and received iv treatment of glucose and humulin (dose/type unknown), heparin, creon, calcium (40 mg), and atorvastain.There was no report of death or permanent injury associated with this event.A sensor reading of 52 mg/dl was compared against a healthcare meter reading of 600 mg/dl, the results, when plotted on a parkes error grid, fell into the 'd' zone showing the difference in values to be clinically significant.
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Manufacturer Narrative
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The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The device manufacturing date is unknown.The date entered in is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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Manufacturer Narrative
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A low reading issue was reported with the adc device.The customer obtained a reading of 52 mg/dl and experienced symptoms of nausea, short breath, chills, and presented to the emergency room.The customer had a cbc, urinalysis, chest x-ray, and heart ultrasound performed.The customer was diagnosed with hyperglycemia and received iv treatment of glucose and humulin (dose/type unknown), heparin, creon, calcium (40 mg), and atorvastain.There was no report of death or permanent injury associated with this event.A sensor reading of 52 mg/dl was compared against a healthcare meter reading of 600 mg/dl, the results, when plotted on a parkes error grid, fell into the 'd' zone showing the difference in values to be clinically significant.
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Search Alerts/Recalls
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