Catalog Number 03666794001 |
Device Problem
Erratic or Intermittent Display (1182)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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The customer complained of missing segments in the results field of the coaguchek xs meter that may impact the interpretation of results.The customer stated when he inserted the test strip the meter beeped but only a "spot' was flashing on the display.He pressed the power button and had one spot flashing.The customer performed a display check and could not see any icons or digits.He could only see 5 dashes across the middle of the display.There was no allegation of an adverse event.The suspect product was requested to be returned for investigation.
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Manufacturer Narrative
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The meter was returned for investigation.Upon investigation of the returned meter, a defect in the circuit board or an electronic component of the circuit board was found.
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Search Alerts/Recalls
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