Model Number 6260 |
Device Problem
Low Readings (2460)
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Patient Problems
Hyperglycemia (1905); Tingling (2171); Cramp(s) (2193); Numbness (2415)
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Event Date 03/01/2020 |
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 as the customer's weight was not provided.
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Event Description
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The customer reported that he obtained three blood glucose readings of below 400 mg/dl on the contour next link 2.4 meter.The customer was experiencing symptoms of hyperglycemia such as tingly and numb feet, leg cramps and lethargy.The customer went to the hospital where his blood glucose level was checked and was found to be above 500 mg/dl.The customer was severely dehydrated.He received serum intravenously and insulin injection to stabilize his glucose levels.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.Since the strip information provided by the customer was not related to this event, this report will be submitted under the meter information.
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Manufacturer Narrative
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The customer returned the suspected contour next link 2.4 meter for evaluation.The customer also returned the contour next test strips from lot # 0apec41a which was not implicated to be involved in the event.The returned meter was tested with the returned test strips using a blood sample, which gave a satisfactory performance.
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Search Alerts/Recalls
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