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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 71371-75
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2017
Event Type  malfunction  
Manufacturer Narrative
The product has been requested back for investigation.A follow- up report will be submitted once additional information is obtained.Note: the sensor is designed to report readings of 20 mg/dl to 500 mg/dl.It should be noted that this meter does not give numeric value for readings less than 20 mg/dl.A "lo" display message indicates a reading less than 20 mg/dl.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported receiving erratic readings on their adc blood glucose meter.Customer reported receiving readings of "lo" (less than 20 mg/dl), 47 mg/dl and 116 mg/dl within 10 minutes.The results when plotted on a parkes error grid fell into the "c" zone showing the difference in values to be clinically significant.There was no report of death, serious injury or mistreatment associated with this event.
 
Manufacturer Narrative
The reported meter was returned and investigated with retained test strips.Control solution testing was performed and no issues were observed.All results were within range specification and no errors were observed during control solution testing.The reported readings were found in the meter's memory.
 
Event Description
Customer reported receiving erratic readings on their adc blood glucose meter.Customer reported receiving readings of "lo" (less than 20 mg/dl), 47 mg/dl and 116 mg/dl within 10 minutes.The results when plotted on a parkes error grid fell into the "c" zone showing the difference in values to be clinically significant.There was no report of death, serious injury or mistreatment associated with this event.
 
Manufacturer Narrative
The reported meter has been previously returned and investigated.No further investigation for the meter will be conducted.A valid serial number for the reported test strips has not been provided.An extended investigation has been performed for the reported test strips and there was no indication that the product did not meet specification.A dhr (device history review) for the precision strips was reviewed and the dhr showed the precision strips passed all tests prior to release.Clinical data was reviewed and confirmed that precision strips continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed for the reported complaint and precision test strips, no further track and trend review as required as there were no confirmed complaints.If the reported test strips are returned, the case will be re-opened and a physical investigation will be performed.
 
Event Description
Customer reported receiving erratic readings on their adc blood glucose meter.Customer reported receiving readings of "lo" (less than 20 mg/dl), 47 mg/dl and 116 mg/dl within 10 minutes.The results when plotted on a parkes error grid fell into the "c" zone showing the difference in values to be clinically significant.There was no report of death, serious injury or mistreatment 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
devin dirstine
1360 south loop road
alameda, CA 94502-7001
5108644391
MDR Report Key7155418
MDR Text Key96125085
Report Number2954323-2017-09218
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
PMA/PMN Number
K142928
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 03/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number71371-75
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2018
Initial Date Manufacturer Received 12/11/2017
Initial Date FDA Received12/29/2017
Supplement Dates Manufacturer Received02/01/2018
02/22/2019
Supplement Dates FDA Received02/21/2018
03/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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