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U.S. Department of Health and Human Services

Class 2 Device Recall Insulin infusion pump (as part of the ACCUCHEK Aviva Combo system)

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 Class 2 Device Recall Insulin infusion pump (as part of the ACCUCHEK Aviva Combo system)see related information
Date Initiated by FirmSeptember 25, 2014
Date PostedOctober 29, 2014
Recall Status1 Terminated 3 on January 10, 2018
Recall NumberZ-0146-2015
Recall Event ID 69323
510(K)NumberK111353 
Product Classification Pump, infusion, insulin - Product Code LZG
ProductACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It is indicated for the treatment of insulin requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician.
Code Information Model/Catalog/Part Number:  Accu-Chek Combo Kit mg US/English version, 05458544001  Accu-Chek Combo Kit mg US/Spanish version, 055004686001  Accu-Chek Spirit Combo Replacement Pump US/EN, 05391512001  Accu-Chek Spirit Combo Demo Pump- US, 0539175000
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactAnne Gill
317-521-4312
Manufacturer Reason
for Recall		The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. If the capacitor fails, the time and date will return to default setting. Though the pump prompts customers to confirm the time and date, if the user does not recognize the time and date have returned to default, a shift of their basal rate time block could occur.
FDA Determined
Cause 2		Equipment maintenance
ActionRoche sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 25, 2014 via UPS Ground (receipt required) to the consignees. The letter included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. No product returns were expected. For questions, contact the ACCU-CHEK Customer Care Service Center at 1-800-688-4578.
Quantity in Commerce8116
DistributionUS Nationwide Distribution in the states of CA, CT, IA, NV, OH, IN, WI, GA, MO, NY, VA, LA, ME, TX, NC, ND, SD, NJ, CO, AL, SC, IL, KY, FL, OR, MN, MD, MS, AR, WV, WA, TN, CT, ID, KS, MI, PA, UT, MA, RI, NM, OK, DE, AZ, NE, MT, NV, WY, AK, and NH.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LZG
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