MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE FREEDOM LITE; BLOOD GLUCOSE MONITORING SYSTEM

Model Number 70914-70

Device Problem Use of Device Problem (1670)

Patient Problems Fatigue (1849); Hypoglycemia (1912)

Event Date 08/28/2017

Event Type  Injury  

Manufacturer Narrative

The date of the event is unknown.The date reported in section is the date abbott diabetes care became aware of the event.A review of freestyle precision test strip label copy was performed as it was identified the customer was using incompatible test strips, freestyle precision, with their freestyle freedom lite meter.The freestyle precision test strip carton lists the meters that are compatible with the test strips on the front of the carton.In addition, the test strip insert lists the meters that are compatible with freestyle precision test strips.A review of label copy did not identify any deficiencies in product labeling for freestyle precision test strips and it was determined to be a use error by the customer.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller (customer¿s companion) reported that the customer¿s adc glucose test strips ¿do not fit in the port¿.As a result, the customer was unable to perform a blood glucose test using his/her adc blood glucose meter.The caller further reported that ¿within the month of (b)(6)¿ on an unspecified date, the customer experienced symptoms of ¿hypoglycemic incident, fatigue.¿ the caller provided the customer with ¿sugar and juice¿ as treatment, as the customer was unable to treat himself/herself.No other treatment was reported.There was no report of death or permanent injury associated with this event.During troubleshooting, it was identified that the customer was using incompatible test strips.

Manufacturer Narrative

Since no product has been returned, extended investigation has been performed for the reported complaint.It has been determined that there was no indication that the product did not meet specification.A dhr (device history review) for the freestyle freedom lite meter has been reviewed and the dhr showed the freestyle freedom lite meter passed all tests prior to release.As stated in the case information, it was determined during troubleshooting that the customer had attempted to use precision strips, which cannot be used with the freedom lite meter.Therefore, no further strip related investigation activities are required.The useful life of the freestyle freedom lite meter is 5 years.As the manufacturing date of this product is oct 12, 2009, it has been in distribution beyond its useful life.Since the product exceeded its useful life, it is determined to have met specification when the product was released and through its lifespan.Therefore, no further investigation activities are required for the freestyle freedom lite meter.If the product is returned, the case will be re-opened and a physical investigation will be performed.

Event Description

A caller (customer¿s companion) reported that the customer¿s adc glucose test strips ¿do not fit in the port¿.As a result, the customer was unable to perform a blood glucose test using his/her adc blood glucose meter.The caller further reported that ¿within the month of august¿ on an unspecified date, the customer experienced symptoms of ¿hypoglycemic incident, fatigue.¿ the caller provided the customer with ¿sugar and juice¿ as treatment, as the customer was unable to treat himself/herself.No other treatment was reported.There was no report of death or permanent injury associated with this event.During troubleshooting, it was identified that the customer was using incompatible test strips.

• Brand Name: FREESTYLE FREEDOM LITE
• 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: 6895944
• MDR Text Key: 87439393
• Report Number: 2954323-2017-06638
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K092602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 70914-70
• Device Lot Number: 4500167886
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2009
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 115