Catalog Number 03666794001 |
Device Problems
Circuit Failure (1089); Failure to Power Up (1476); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/29/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The meter was requested to be returned for investigation.The investigation is ongoing.
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Event Description
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There was an allegation of a melted battery cover for a coaguchek xs meter.The patient's meter would not power on.The patient changed the batteries and reset the meter.The back of the battery door appeared to be melted and one of the batteries showed signs of corrosion.
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Manufacturer Narrative
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The investigation reviewed the picture of the meter's battery cover and confirmed there was residue from a leaked battery.The meter was provided for an investigation.The investigation could not turn on the meter.The device data and fault memory were read out.A visual examination was performed.The batteries used by the user were not returned.The deposits from a leaking battery were found in the battery compartment.This also affects the battery contact, which was temporarily interrupted as a result.Per product labeling, "if you store the meter for a period of time, remove the batteries." the investigation determined the issue was consistent with improper meter handling.The investigation did not identify a product problem.
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Search Alerts/Recalls
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