MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE PRECISION PRO; BLOOD GLUCOSE MONITORING SYSTEM

Model Number 71411-70

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 05/19/2019

Event Type  Injury  

Manufacturer Narrative

This is an initial final report. this issue does not meet reportability criteria, however it is being reported to fda as the complaint was received via user report.If product is returned, this case will be re-opened, an investigation will be conducted,  and a follow-up report will be submitted after all investigation activities are complete.The device mfg date 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

Abbott diabetes care received a medwatch report which contained the following information: customer from the point of care team reported that 9 of their adc blood glucose meters were reading the barcodes of the patients incorrectly.The adc meter uses the encounter numbers to identify the patient through a bi-directional adt interface and nurse scan the patient armband liner barcode prior to running the glucose test.One of the patient was identified because they had been admitted from emergency department to the medical unit and most of the patients were seen in the emergency department.An additional test was performed and reported that the barcodes were read incorrectly.It was reported that there were 9 barcode patient id failures with 6 different patients.No medical treatment related to the issue was reported on the user report.No further information was provided.Based on the information provided, there was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE PRECISION PRO
• 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 Key: 8932885
• MDR Text Key: 155630869
• Report Number: 2954323-2019-06555
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71411-70
• Device Catalogue Number: 71411-70
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1