IPRO CARELINK THERAPY MANAGEMENT SOFTWARE (2017-10-10)

Starting date:

October 10, 2017

Posting date:

November 10, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-65062

• Reason
• Affected products

Affected products

IPRO CARELINK THERAPY MANAGEMENT SOFTWARE

Reason

Due to a time conversion error, data uploaded from the iPro2 recorder to the CareLink iPro software using the new CareLink iPro uploader feature may result in incorrect reports. This pertains only to reports generated between September 23, 2017 and September 27, 2017 that used the new CareLink iPro uploader feature. Specifically, when data from the iPro2 recorder was uploaded using the new CareLink iPro uploader feature, the glucose reading timestamps inadvertently defaulted to Greenwich Mean Time (GMT) /Coordinated Universal Time (UTC). Manufacturer determined that the difference in time zones could result in calculation and display errors on the reports. This could lead to potential differences or inaccuracies in the sensor tracings, which also affect the display of meals and activities and the resulting report.

Affected products