Model Number 70914-70 |
Device Problem
Power Problem (3010)
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Patient Problem
No Information (3190)
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Event Date 06/26/2020 |
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 exact date the incident occurred is unknown.The date entered is per the customer's report of "two weeks ago".All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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The customer reported unspecified power/battery issue with the adc blood glucose meter that occurred "two weeks ago".The customer reported that she could not use meter due to battery replacement, and subsequently was admitted to icu.It is unknown if battery replacement was required due to battery life ending, a product issue, or if replacement caused a product issue.No further information was given as customer refused to continue troubleshooting, and attempts to gather additional information has thus far been unsuccessful.There was no report of death or permanent injury 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 there was no indication that the product did not meet specification. dhr (device history review) for the freestyle freedom lite meter was reviewed and the dhr showed the freestyle freedom lite meter passed all tests prior to release. if the product is returned, the case will be re-opened, and a physical investigation will be performed.
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Event Description
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The customer reported unspecified power/battery issue with the adc blood glucose meter that occurred "two weeks ago".The customer reported that she could not use meter due to battery replacement, and subsequently was admitted to icu.It is unknown if battery replacement was required due to battery life ending, a product issue, or if replacement caused a product issue.No further information was given as customer refused to continue troubleshooting, and attempts to gather additional information has thus far been unsuccessful.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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