Model Number 7312 |
Device Problem
High Readings (2459)
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Patient Problem
Syncope/Fainting (4411)
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Event Date 09/13/2022 |
Event Type
Injury
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Event Description
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The customer reported that he performed blood glucose testing with the contour next link 2.4 meter and the reading obtained on the meter was higher than that on the insulin pump.No specific readings were provided.The insulin pump delivered insulin based on the incorrect reading and the customer fainted.The customer stated that the event occurred three times and every time he had to call an emergency service.The customer stated that the physician adjusted the insulin pump to deliver right amount of insulin.No further event details were provided.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.
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Manufacturer Narrative
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As per contour next link 2.4 blood glucose monitoring system user guide, "wash hands and dry well before handling to keep the meter and test strips free of water, oils and other contaminants.Please follow all instructions for use and care exactly as described to help avoid inaccurate results." the customer did not wash his hands prior to testing.The patient/family was the initial reporter, so personal information was not entered.No information was captured in section a4 as the customer's weight was not provided.
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Manufacturer Narrative
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The customer did not return the device for evaluation.Therefore, an in-house testing was performed using blood sample with the in-house contour next link 2.4 meter and in-house contour next test strips from lot#: 1epeg11a, which gave a satisfactory performance.Additionally, a device history record was reviewed for the suspected contour next link 2.4 meter and no manufacturing anomalies were found.
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Search Alerts/Recalls
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