Catalog Number 03666794001 |
Device Problem
Thermal Decomposition of Device (1071)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The customer¿s meter was requested for return.The investigation is ongoing.
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Event Description
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The initial reporter complained of a burning or charring issue with coaguchek xs meter serial number (b)(4).The customer complained of various error messages (example: error 4) and was unable to perform a test.It was noted that the heater plate appeared to be charred or burnt.There were no other signs of burning, melting, or smoking to any other portion of the meter.
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Manufacturer Narrative
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The customer's meter was received for investigation.The meter¿s circuit board was tested for damage or contamination and it was found the test strip area (tsa) was badly damaged by a fall.As a result, the capacitor c248 was torn off, the test strip contacts were badly damaged and the heating ceramic was broken (handling error).The heating ceramic shows no signs of burning.The root cause is determined to be damage due to improper handling or maintenance by the customer.
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Search Alerts/Recalls
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