Model Number 9697 |
Device Problem
Low Readings (2460)
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Patient Problems
Head Injury (1879); Loss of consciousness (2418)
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Event Date 05/31/2020 |
Event Type
Injury
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Manufacturer Narrative
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The patient/family was the initial reporter, so personal information was not entered.No information was captured in section as the customer's weight was not provided.
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Event Description
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An advocate reported that the customer obtained a low reading on the contour next meter.No specific reading was provided.As the reading on the meter was low, she did not take her medication and experienced symptoms of hyperglycemia.The customer passed out and injured her head.The customer was taken to the hospital and her blood sugar levels were high.The customer was admitted to the rehabilitation facility.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.Since the strip information was not provided, this report will be submitted under the meter information.
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Manufacturer Narrative
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The customer did not return the device for evaluation.Since the lot # of the suspected test strips was not provided, the in-house testing could not be performed.Therefore, a device history record was reviewed for the suspected contour next meter and no manufacturing anomalies were found.
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Search Alerts/Recalls
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