Model Number 75175-83 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Weakness (2145); Loss of consciousness (2418)
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Event Date 10/28/2020 |
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.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported a precision glucose reading issue when testing on the adc meter compared to an hcp meter.The customer further reported receiving error-7 error and the meter turns off after the test was performed.The customer experienced symptoms described as ¿stiffness, weakness, and a loss of consciousness¿ and was unable to self-treat.The customer¿s wife attempted to treat with coke but couldn't therefore, an ambulance was called.Upon the ambulance arrival, a blood glucose reading of 44 mg/dl was obtained on the hcp meter, the customer was diagnosed with hypoglycemia and treated with 20mg glucosum and infusion of 200mg and 50ml intravenously.No further information was provided.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 and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was completed for the reported complaint and fs neo meter xido optium, and there were no adverse trends that indicate any potential product-related issues.Dhrs (device history review) for the precision strips were reviewed and the dhrs showed the precision strips passed all tests prior to release.Retain testing was performed for precision strips and all units performed in the specification and passed.If the product is returned, the case will be re-opened, and a physical investigation will be performed.Section d4 (serial number) has been updated to unk.The meter serial number provided to adc by the customer at the time of the call and subsequently captured in the initial report (b)(6) was deemed to be invalid upon extended investigation.
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Event Description
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A customer reported a precision glucose reading issue when testing on the adc meter compared to an hcp meter.The customer further reported receiving error-7 error and the meter turns off after the test was performed.The customer experienced symptoms described as ¿stiffness, weakness, and a loss of consciousness¿ and was unable to self-treat.The customer¿s wife attempted to treat with coke but couldn't therefore, an ambulance was called.Upon the ambulance arrival, a blood glucose reading of 44 mg/dl was obtained on the hcp meter, the customer was diagnosed with hypoglycemia and treated with 20mg glucosum and infusion of 200mg and 50ml intravenously.No further information was provided.There was no report of death or permanent injury associated with this event.
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Event Description
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A customer reported a precision glucose reading issue when testing on the adc meter compared to an hcp meter.The customer further reported receiving error-7 error and the meter turns off after the test was performed.The customer experienced symptoms described as ¿stiffness, weakness, and a loss of consciousness¿ and was unable to self-treat.The customer¿s wife attempted to treat with coke but couldn't therefore, an ambulance was called.Upon the ambulance arrival, a blood glucose reading of 44 mg/dl was obtained on the hcp meter, the customer was diagnosed with hypoglycemia and treated with 20mg glucosum and infusion of 200mg and 50ml intravenously.No further information was provided.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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The returned meter was investigated with retained test strips.Meter powered on with button depression and test strip insertion.No new issues were observed.Control solution testing has been performed.Meter did not shut off during testing.The complaint was not confirmed.No strips have been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the freestyle xido optium neo meter was reviewed and the dhrs showed the freestyle xido optium neo meter passed all tests prior to release.The dhrs (device history review) for the precision strips were reviewed and the dhrs showed the precision strips passed all tests prior to release.Retain testing was performed for precision strips, and all units performed in specification and passed.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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