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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE PRECISION NEO; BLOOD GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE PRECISION NEO; BLOOD GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 75175-83
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Weakness (2145); Loss of consciousness (2418)
Event Date 10/28/2020
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
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.
 
Manufacturer Narrative
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.
 
Event Description
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.
 
Event Description
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.
 
Manufacturer Narrative
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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Brand Name
FREESTYLE PRECISION NEO
Type of Device
BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
erica frank
1360 south loop road
alameda, CA 94502-7001
5108644472
MDR Report Key10824312
MDR Text Key215893254
Report Number2954323-2020-10443
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K140371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 01/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date08/31/2021
Device Model Number75175-83
Device Lot Number4500183344
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received01/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/04/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age45 YR
Patient SexMale
Patient Weight57 KG
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