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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 130 04 14 000
Date submitted: 4/24/2014
Manufacturer:Roche Diagnostics GmbH
Device Type:Insulin Pumps, Accu-Chek Spirit Combo
Description:Infusion Pumps, Insulin, Ambulatory
Medical Device Identifier:Accu-Check Spirit Combo Insulin Pumps
Serial Nos.: 10171897 through 10281629
Reason of Field Safety Corrective Action:There is an increased risk that the vibration alarm will not work, as a result of a changed component. This fault will only be detected at pump start up, when it will display an ‘E-7’ error message and give an audible signal, but will fail to start
Remedy Action:Identify any affected pumps in your inventory.
If a delay to insulin therapy may compromise patient safety, consider using an alternate device.

When using these pumps:
ensure that users are aware of the problem
ensure that users have a syringe or insulin pen available in case the pump stops.

if the pump displays an ‘E-7’ error, contact Roche for a replacement
Athorized Representative/Importer/Distributor:FAROUK, MAAMOUN TAMER & COMPANY, Riyadh, (011) 4142200
Report Source:NCAR
Source Ref. Number:UK-2014-04-17-080
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments