Model Number 98814-65 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Weakness (2145); Dizziness (2194)
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Event Date 09/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The meter serial number is unknown, therefore the device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An error message was reported with the adc meter.Customer reported receiving a recurring error 2 and experiencing symptoms described as weakness and dizziness.Customer had contact with an hcp and was provided "sweet drink and sweet food" for treatment.No further details were provided.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A valid serial number has not been provided for the meter.Dhrs (device history review) for the precision strips was reviewed and the dhrs showed the precision strips passed all tests prior to release.Retain testing was performed and all units performed within specification.A tripped trend review was conducted for the reported complaint and xceed meter, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed, and a follow-up report submitted.
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Event Description
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An error message was reported with the adc meter.Customer reported receiving a recurring error 2 and experiencing symptoms described as weakness and dizziness.Customer had contact with an hcp and was provided "sweet drink and sweet food" for treatment.No further details were provided.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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