Date Initiated by Firm |
October 25, 2013 |
Date Posted |
November 22, 2013 |
Recall Status1 |
Terminated 3 on January 14, 2015 |
Recall Number |
Z-0385-2014 |
Recall Event ID |
66605 |
510(K)Number |
K111353
|
Product Classification |
System, test, blood glucose, over the counter - Product Code NBW
|
Product |
ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\
The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger. |
Code Information |
AccuChek Aviva Combo meter 05075645005 packaged in Accu-Chek Combo Kit mg US/English version, 05458544001 and Accu-Chek Combo Kit mg US/Spanish version, 05504686001. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Operations, Inc. 9115 Hague Rd Indianapolis IN 46256-1025
|
For Additional Information Contact |
Todd Siesky 317-576-2000 Ext. 249
|
Manufacturer Reason for Recall |
There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases, when the Manual Pump option is chosen on the ACCU-CHEK Aviva Combo meter, there is a possibility of receiving an incorrect bolus advice recommendation that may cause a temporary under delivery of insulin.
|
FDA Determined Cause 2 |
Software design |
Action |
The firm, Roche Diagnostics, sent an "URGENT MEDICAL DEVICE CORRECTION (UMDC)" letter dated October 29, 2013, via UPS to their consignees/customers. The letter described the product, problem and actions to be taken. The UMDC informed them of the software synchronization issue with the ACCU-CHEK Combo system that may cause a temporary under delivery of insulin. The customers were instructed to ensure they properly deliver the correction bolus when utilizing the Manual Pump option, as instructed in the Owners Booklet; and complete and return the Business Reply Card via fax to 1-877-282-0223. The Distributors were instructed to provide the UMDC to their direct customers. The HCPs were instructed to remind their patients to follow the instructions in the Accu-Chek Aviva Combo Meter Advanced Owners Booklet when utilizing Manual Pump option.
Questions about the information contained in this UMDC are directed to ACCU-CHEK Pump Support, 24 hours a day, seven days a week at 1-800-688-4578. |
Quantity in Commerce |
6,595 units |
Distribution |
Nationwide Distribution. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = NBW and Original Applicant = Roche Diagnostics
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