Model Number 70805-70 |
Device Problems
No Device Output (1435); Unable to Obtain Readings (1516)
|
Patient Problem
Hypoglycemia (1912)
|
Event Date 09/27/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history review) for the freestyle freedom lite meter and freestyle freedom lite strips were reviewed and the dhrs showed the freestyle freedom lite meter passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date the incident occurred 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.
|
|
Event Description
|
A customer reported that their adc device did not start after the blood sample was applied and as a result, the customer was unable to obtain readings.The customer further reported that their blood glucose was getting low, and felt weak.The customer called the ambulance and they were administered glucose for the diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.
|
|
Event Description
|
A customer reported that their adc device did not start after the blood sample was applied and as a result, the customer was unable to obtain readings.The customer further reported that their blood glucose was getting low, and felt weak.The customer called the ambulance and they were administered glucose for the diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.
|
|
Manufacturer Narrative
|
Meter (b)(6) has been returned and investigated.Visual inspection has been performed on the returned meter and no issues were observed.The returned meter was investigated with retained test strips.Meter powered on with button depression and test strip insertion.Control solution testing has been performed and the test started after the sample was applied.Therefore this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
|
|
Search Alerts/Recalls
|