Model Number 71501-01 |
Device Problem
Thermal Decomposition of Device (1071)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The product has been requested back for investigation.A follow- up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A caller reporting on behalf of her father indicated that the display of his adc glucose meter is "all burnt and there was just a burning smell." the caller further reported: "that meter got on fire inside the meter and it burn out by itself and the screen on the meter is color brown and yellowish and it smells burn." the caller verified that the customer did not observe visible fire or smoke coming from the meter, but the caller did indicate that after her dad took a blood glucose test the meter suddenly burned out.No adverse event was reported.No third party medical intervention was reported.
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Manufacturer Narrative
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The reported meter was returned and extended investigation is pending at this time.A final report will be submitted once additional information is received.
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Event Description
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A caller reporting on behalf of her father indicated that the display of his adc glucose meter is "all burnt and there was just a burning smell." the caller further reported: "that meter got on fire inside the meter and it burn out by itself and the screen on the meter is color brown and yellowish and it smells burn." the caller verified that the customer did not observe visible fire or smoke coming from the meter, but the caller did indicate that after her dad took a blood glucose test the meter suddenly burned out.No adverse event was reported.No third party medical intervention was reported.
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Manufacturer Narrative
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Visual inspection has been performed on the reported meter.Evidence of of fire, smoke, electric shock, and/or explosion was observed.Meter was unable to turn on with the start button or usb cable insertion.Further investigation was completed and the meter was de-cased.A burned daughter pcb (printed circuit board) was observed which, caused the lcd to catch fire.The complaint is not confirmed due to use issue.
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Event Description
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A caller reporting on behalf of her father indicated that the display of his adc glucose meter is "all burnt and there was just a burning smell." the caller further reported: "that meter got on fire inside the meter and it burn out by itself and the screen on the meter is color brown and yellowish and it smells burn." the caller verified that the customer did not observe visible fire or smoke coming from the meter, but the caller did indicate that after her dad took a blood glucose test the meter suddenly burned out.No adverse event was reported.No third party medical intervention was reported.
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Manufacturer Narrative
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The returned meter underwent extended investigation and burn marks were observed on several internal components, including the display, strip port, and printed circuit board.However, the investigation concluded that the damage to the internal components was not caused by the meter itself.The freestyle lite meter is a battery-operated device with a coin cell battery (3v), which cannot generate enough power to melt or burn the internal components as seen in the returned unit.Adcs investigation demonstrated that the power required to cause the observed damages did not originate from within the meter itself.No product deficiency was identified and this issue is therefore not confirmed.
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Event Description
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A caller reporting on behalf of her father indicated that the display of his adc glucose meter is "all burnt and there was just a burning smell." the caller further reported: "that meter got on fire inside the meter and it burn out by itself and the screen on the meter is color brown and yellowish and it smells burn." the caller verified that the customer did not observe visible fire or smoke coming from the meter, but the caller did indicate that after her dad took a blood glucose test the meter suddenly burned out.No adverse event was reported.No third party medical intervention was reported.
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Search Alerts/Recalls
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