Model Number 9697 |
Device Problem
Missing Test Results (3267)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The patient/family (a1) was the initial reporter (e1), so personal information was not entered.No information was captured in sections a2 and a4 as the customer's age and weight were not provided.
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Event Description
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The customer reported that after she changed the battery on the contour next meter, the time and date on the meter were set incorrectly and her blood glucose readings were not being stored in the memory of the meter.There was no allegation of an adverse event.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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The customer returned the suspected contour next meter for evaluation.No test strips were returned.An in-house testing was performed with the returned meter and in-house contour next test strips using blood sample, which gave a satisfactory performance.The blood glucose readings obtained during the in-house testing were properly stored in the meter's memory.
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Search Alerts/Recalls
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