Model Number 98814-65 |
Device Problem
Calibration Problem (2890)
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Patient Problems
Hyperglycemia (1905); Weakness (2145); Dizziness (2194)
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Event Date 01/21/2017 |
Event Type
Injury
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Manufacturer Narrative
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The customer¿s products have been requested for an investigation.A follow-up report will be filed once additional information is obtained.The device manufacturer date for the reported meter serial number is unknown.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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On (b)(6) 2017 a customer reported that her adc blood glucose meter had a calibration issue and would not provide a reading when a test strip was inserted.On (b)(6), the customer called back to inquire about the delivery status of the replacement meter that had not arrived.She also reported experiencing a medical event as a result of being unable to test her blood glucose.The customer reported that on (b)(6), she felt ¿dizzy and weak¿, and her husband took her to the emergency room.At the hospital emergency room, the customer¿s blood glucose was measured at 392 mg/dl and she was diagnosed with hyperglycemia.The customer was treated with ¿insulin and serum intravenously¿.
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Manufacturer Narrative
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No product was returned for this complaint and a valid serial/lot number was not provided.Reviews of all dhrs for all strips within expiration at the time of complaint was performed and the dhr review showed no there were no deviations from the validated manufacturing process.
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Event Description
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On (b)(6) 2017 a customer reported that her adc blood glucose meter had a calibration issue and would not provide a reading when a test strip was inserted.On (b)(6) the customer called back to inquire about the delivery status of the replacement meter that had not arrived.She also reported experiencing a medical event as a result of being unable to test her blood glucose.The customer reported that on (b)(6) she felt ¿dizzy and weak¿, and her husband took her to the emergency room.At the hospital emergency room, the customer¿s blood glucose was measured at 392 mg/dl and she was diagnosed with hyperglycemia.The customer was treated with ¿insulin and serum intravenously¿.
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Search Alerts/Recalls
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