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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 No Device Output (1435); Unable to Obtain Readings (1516)
Patient Problem Hypoglycemia (1912)
Event Date 12/11/2023
Event Type  Injury  
Manufacturer Narrative
The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.The product has been requested back for an investigation.At this time product has not yet 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 conducted for the freestyle precision neo meter and the reported complaint and 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.The date of event is unknown.The date entered in section b3 (date of event) is based on the customer's reported date of between the second and third week of december.The device mfg date is unknown.The date entered in section h4 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 testing issue was reported with the adc reader.The test did not start after the blood sample was applied and customer was unable to obtain readings.As a result, the customer experienced hypoglycemia and had difficulty in speaking.The customer was given treatment of water with sugar and custard that was provided by a healthcare professional.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
The returned meter was investigated with retained test strips and known good retained battery.Meter power on with button depression.Meter did not power on with bar insertion.Port-2 issue has been created to address this issue.The meter was de-cased and internal visual inspection was performed on returned meter.Liquid contamination was observed on the strip port pins.Issue not confirmed to use.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the freestyle optium neo meter was reviewed and the dhrs showed the freestyle optium neo meter passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A testing issue was reported with the adc reader.The test did not start after the blood sample was applied and customer was unable to obtain readings.As a result, the customer experienced hypoglycemia and had difficulty in speaking.The customer was given treatment of water with sugar and custard that was provided by a healthcare professional.There was no report of death or permanent impairment associated with this event.
 
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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
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key18466496
MDR Text Key332331934
Report Number2954323-2024-00765
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeSP
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
Report Date 02/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number75175-83
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received02/09/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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