Catalog Number 03666794001 |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2023 |
Event Type
malfunction
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Event Description
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We received an allegation about an odd display when the patient tried to test on a coaguchek xs meter.The patient's husband alleged that once he released the power button, the meter showed a flashing strip icon and < rrr sec in the results field with the time and date above it.The patient's husband stated the display issue began on 28-oct-2023 when the patient ran a test which resulted in 1.6 inr and believed to be low.The display appeared dim at that time too.Reportedly, the patient's warfarin dosage was increased based on the meter result of 1.6 inr on 28-oct-2023.The patient¿s therapeutic range was 2.0-3.0 inr.
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Manufacturer Narrative
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Section e: the reporter is the patient's/consumer's husband.On the call, a display test was performed.The meter memory was also reviewed and it showed 1.6 inr on 28-oct-2023.The meter showed that it was coded correctly.The patient's meter was requested for investigation.The patient has apas.Product labeling states: "the presence of anti-phospholipid antibodies (apas) such as lupus antibodies (la) may lead to prolonged clotting times, i.E., they may cause false-high inr values.If you have or suspect that you have apas, discontinue testing until you discuss with your physician." the investigation is ongoing.
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Manufacturer Narrative
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The meter was provided for investigation where the device data and fault memory were read out.A display test was performed and the circuit board was tested for damage or contamination.The circuit board showed contamination caused by a penetrated liquid which affected the conductive rubber contacts.Some segments were only displayed with a weak contrast.The investigation did not identify a product problem.There was a user error.The root cause was contamination of the contacts due to improper handling or maintenance.
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Search Alerts/Recalls
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