Model Number STRIP, TMX PBX 50CTMG/DL |
Device Problem
High Test Results (2457)
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Patient Problems
Headache (1880); Hyperglycemia (1905); No Code Available (3191)
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Event Date 12/06/2019 |
Event Type
Injury
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Manufacturer Narrative
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Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-58: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Note: manufacturer contacted customer in a follow-up call to ensure that the customer's condition improved - able to establish contact with customer and on follow-up call on 12/09/2019, the customer's condition had improved and she did not currently have any diabetic symptoms.Customer stated that she had a headache but that it was due to a mass on her brain and was unrelated to her diabetes.Customer stated that she had been hospitalized from (b)(6) 2019 - (b)(6) 2019.Customer's blood glucose test result when admitted to the hospital was 577 mg/dl; customer did not recall her diagnosis, only that hospital was concerned with her high glucose level.Customer was treated with iv fluids, a humalog pump, and lantus.Customer's blood glucose test result when discharged from the hospital was 357 mg/dl.Customer's levothyroxine was increased from 150 mcg to 175 mcg.Customer has tested using the truemetrix meter and obtained a result of 170 mg/dl fasting; customer was satisfied with the product.
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Event Description
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Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 577 and 549 mg/dl.The customer¿s expected blood glucose test result range was not provided.At the time of the call, the customer stated she felt tired, had a headache and had sweet breath.Customer stated that she knows her blood glucose is high was going to call 911.No further information was able to be obtained.
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Manufacturer Narrative
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Sections with additional information as of 20-feb-2020: h10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested and passed.
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Search Alerts/Recalls
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