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OECDReference EN/AU/PS1105248

Accu-Chek Solo Cannula Assembly & Pump Holder and Accu-Chek Solo Supply Kit

Official information organised for easier consultation. The source publication remains authoritative.

Identification

Product identification

Product
Accu-Chek Solo Cannula Assembly & Pump Holder and Accu-Chek Solo Supply Kit

Official information

Risk and measures

Risk or hazard
Insulin leakage has occurred with the Accu-Chek Solo Cannula Assembly and  Pump Holder. If the insulin leakage is not immediately noticed when using the Accu-Chek Solo system this could potentially lead to an under-delivery of insulin. If insulin is under-delivered, this may lead to  adverse health events including severe hyperglycaemia or the user may experience diabetic ketoacidosis (DKA) and may require hospitalisation or intervention from a medical professional.
Recommendations
Consumers should check whether they have an affected product and if so stop using them.  Consumers should contact Roche Diabetes Customer Care to make arrangements to receive a replacement. For more details see https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01541-1 For further information, please contact Roche Diabetes Customer Care by phone on 1800 251 516.

Official information

Economic operators

Manufacturer
Roche Diabetes Care Australia Pty Limited

Territory

Geography

Distribution
Retirada en Australia
Country of recall
Australia

Provenance and context

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