—#143632

Product

Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be use with single-use, auto-disabling lancing devices.

FDA product code: LFR — Glucose Dehydrogenase, Glucose
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K121679
Affected lot / code info: Model/Catalog/Part Number: 05060290001; serial numbers: UU41000000 through UU41064963 and UU41064964 through UU41122741.

Why it was recalled

Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The issue can lead to the data loss or in the worst case to an erroneous assignment of the patient data (patient mismatch). The issue will only occur at sites using POTCT1-A communication via USB.

Root cause (FDA determination)

Software Design Change

Action the firm took

Roche sent an URGENT MEDICAL DEVICE RECALL CORRECTION letter dated February 11, 2016, via UPS Ground (receipt required) to the consignee. The Consignee instructions were as follows: If currently using USB connectivity, follow the instructions outlined in this Urgent Medical Device Correction (UMDC) to determine if your base unit is affected by the issue. Until the new software is available, do not use USB connectivity if the base unit is affected by this issue; switch the connectivity method to Ethernet (TCP/IP) or Wi-Fi. Roche is not requesting return of affected product. Any returned product will be managed according to current procedures. Consignees with questions were instructed to contact the ACCU-CHEK Customer Care Service Center at 1-800-440-3638. For questions regarding this recall call 317-521-3911.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, and WV.

Timeline

Recall initiated: 2016-02-11
Posted by FDA: 2016-03-14
Terminated: 2017-05-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143632. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.