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

Catalog Number 70805-70

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2014

Event Type  malfunction  

Event Description

Customer initially reported that their adc meter did not turn on.The product was returned and investigated.This mdr is being submitted due to returned product investigation results.There was no report of death, serious injury or mistreatment associated with this event.

Manufacturer Narrative

Investigation of the returned product determined the cause to be isolated to software corruption.Although glucose results may be delayed, blood glucose could be determined by alternate means, including use of another blood glucose meter, seeing a physician (as recommended in product labeling), or by seeking treatment at a health care facility.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE FLASH
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; 1360 south loop road; alameda CA 94502 700
• Manufacturer Contact: meg manager ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 4528604
• MDR Text Key: 5505031
• Report Number: 2954323-2015-00085
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2014

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 Catalogue Number: 70805-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2015
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1