Model Number XS PST |
Device Problem
Material Discolored (1170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/19/2022 |
Event Type
malfunction
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Event Description
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We received an allegation of a brown scorch-like mark on the heater plate of the coaguchek xs meter.The meter powers off and resets after pressing the "m" button.The reporter cleaned the heater plate to troubleshoot per instructions from the user's manual.The reporter stated that there was a brown scorch-like mark at the bottom left corner and outwards on the heater plate.The mark did not disappear upon cleaning.
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Manufacturer Narrative
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The meter was requested for investigation.Occupation is patient/consumer: na.
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Manufacturer Narrative
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The meter was returned for investigation.The meter and circuit board were checked for contamination or damage.Clear contamination from dried blood was seen on the heating ceramic.Blood contamination was be seen on the test strip contacts.No other device contamination was observed.The contamination on the heating ceramic is not a scorch mark, since on closer inspection traces of dried liquid are visible.The energy for such a selective overheating cannot be generated in the device.The root cause is determined to be contamination of the contacts due to improper handling or maintenance by the customer.
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Search Alerts/Recalls
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