Class 2 Device Recall One Touch Ping Glucose Monitoring System

• Date Initiated by Firm: August 04, 2008
• Date Posted: November 07, 2008
• Recall Status: Terminated on November 12, 2008
• Recall Number: Z-0283-2009
• Recall Event ID: 49475
• 510(K)Number: K080639
• Product Classification: Insulin Infusion Pump - Product Code LZG
• Product: One Touch Ping Glucose Monitoring System Combines the functionality of OneTouch(R) Ping (TM) Insulin Pump and a OneTouch(R) Ping (TM) Meter Remote through radio frequency (RF) communication. Together, they provide an option to help make insulin delivery more discreet and flexible. Also, allows the most recent blood glucose results from the OneTouch(R) Ping (TM) Meter Remote to be automatically entered into bolus insulin calculations to cover carbohydrates in food or to correct for a high blood glucose level.
• Code Information: Part numbers: 100-430-00, 100-431-00, 100-432-00, 100-434-00, and 100-435-00. Serial numbers: 01-02000-15, 02-02001-15, 03-02002-15, 04-02003-15, 04-02010-15, 05-02004-15, 05-02011-15, 06-02012-15, 06-02100-15, 07-02013-15, 07-02101-15, 08-02007-15, 08-02102-15, 09-02008-15, 09-02110-15, 10-02009-15, 10-02104-15, 10-02111-15, 11-02112-15, 12-02032-15, 12-02106-15, 12-02113-15, 12-02120-15, 13-02033-15, 13-02040-15, 13-02107-15, 13-02121-15, 13-02202-15, 14-02027-15, 14-02034-15, 14-02108-15, 14-02203-15, 14-02210-15, 15-02028-15, 15-02035-15, 15-02042-15, 15-02123-15, 15-02204-15, 16-02029-15, 16-02036-15, 16-02050-15, 16-02117-15, 16-02124-15, 16-02131-15, 16-02205-15, 16-02300-15, 17-02037-15, 17-02051-15, 17-02118-15, 17-02132-15, 17-02213-15, 17-02220-15, 18-02038-15, 18-02126-15, 18-02140-15, 18-02221-15, 19-02039-15, 19-02053-15, 19-02060-15, 19-02127-15, 19-02208-15, 19-02222-15, 20-02047-15, 20-02054-15, 20-02142-15, 20-02209-15, 20-02216-15, 20-02223-15, 20-02304-15, 21-02048-15, 21-02129-15, 21-02136-15, 21-02143-15, 21-02150-15, 21-02217-15, 21-02224-15, 21-02231-15, 22-02049-15, 22-02056-15, 22-02063-15, 22-02144-15, 22-02151-15, 22-02225-15, 22-02232-15, 23-02057-15, 23-02071-15, 23-02152-15, 23-02219-15, 23-02233-15, 23-02240-15, 24-02058-15, 24-02065-15, 24-02072-15, 24-02139-15, 24-02160-15, 24-02241-15, 25-02059-15, 25-02066-15, 25-02080-15, 25-02147-15, 25-02228-15, 25-02235-15, 26-02148-15, 26-02155-15, 26-02162-15, 26-02236-15, 26-02243-15, 26-02250-15, 26-02331-15, 27-02149-15, 27-02156-15, 27-02163-15, 27-02237-15, 27-02244-15, 28-02076-15, 28-02090-15, 28-02157-15, 28-02164-15, 28-02171-15, 28-02245-15, 28-02319-15, 28-02333-15, 29-02091-15, 29-02158-15, 29-02172-15, 29-02246-15, 29-02253-15, 29-02260-15, 30-02092-15, 30-02166-15, 30-02173-15, 30-02180-15, 30-02247-15, 30-02254-15, 30-02261-15, 30-02342-15, 31-02093-15, 31-02167-15, 31-02248-15, 31-02255-15, 31-02262-15, 31-02336-15, 32-02094-15, 32-02168-15, 32-02175-15, 32-02256-15, 32-02263-15, 32-02351-15, 33-02088-15, 33-02169-15, 33-02176-15, 33-02190-15, 33-02345-15, 34-02096-15, 34-02177-15, 34-02184-15, 34-02191-15, 34-02258-15, 35-02178-15, 35-02185-15, 35-02192-15, 35-02259-15, 36-02098-15, 36-02186-15, 36-02193-15, 36-02348-15, 37-02099-15, 37-02195-15, 39-02189-15, 39-02196-15, 40-01901-15, 40-02197-15, 41-02198-15, 42-01910-15, 42-02199-15, 43-01911-15, 44-01912-15, 45-01906-15, 45-01913-15, 45-01920-15, 48-01909-15, 49-01924-15, 49-01931-15, 50-01918-15, 50-01925-15, 51-01926-15, 51-01940-15, 52-01927-15, 52-01934-15, 52-01941-15, 53-01928-15, 53-01942-15, 54-01936-15, 54-01943-15, 54-01950-15, 55-01951-15, 56-01864-15, 56-01938-15, 56-01952-15, 57-01939-15, 57-01946-15, 57-01953-15, 57-01960-15, 58-01866-15, 58-01873-15, 58-01947-15, 58-01961-15, 59-01874-15, 59-01948-15, 59-01948-15, 60-01868-15, 60-01882-15, 60-01949-15, 60-01963-15, 60-01970-15, 61-01869-15, 61-01876-15, 61-01883-15, 61-01890-15, 61-01957-15, 62-01877-15, 62-01884-15, 62-01891-15, 62-01958-15, 63-01885-15, 63-01892-15, 63-01959-15, 63-01973-15, 64-01886-15, 64-01893-15, 64-01974-15, 64-01981-15, 65-01887-15, 67-01889-15, 67-01896-15, 67-01991-15, 68-01897-15, 68-01985-15, 68-01992-15, 69-01898-15, 69-01979-15, 69-01993-15, 70-01899-15, 70-01987-15, 70-01994-15, 71-01995-15, 72-01996-15, 73-01997-15, 74-01998-15, and 75-01999-15.
• Recalling Firm/ Manufacturer: Animas Corporation; 200 Lawrence Dr; West Chester PA 19380
• For Additional Information Contact: Rita McIntyre; 610-644-8990
• Manufacturer Reason for Recall: display old, inaccurate values for bolus amount delivered and amount of planned bolus totals
• FDA Determined Cause: Software design
• Action: On 8/6/08, the recalling firm telephoned all users to inform them of problem and the need to return the system.
• Quantity in Commerce: 251 units
• Distribution: Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = LZG