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| Issued: 15 December 2006 at 11:30 |
Ref: MDA/2006/070
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Immediate action |
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Action |
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Update |
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Information request |
| This alert replaces the guidance issued on 04 May 2005 in MDA/2005/026, which has now been withdrawn. | |||||||||||
| Device: LifeScan OneTouch® Ultra®, LifeScan InDuo® and LifeScan PocketScan® blood glucose meters. |
>Page 2 |
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| Problem: The units of measurement displayed may change from mmol/L to mg/dL, resulting in the user thinking that the blood glucose level is too high and thus altering the treatment regime inappropriately. |
>Page 2 |
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Action by:
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| Action: Details on pages 2 and 3. |
>Pages 2&3 |
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Distributed to:
* via CE Bulletin |
>Page 3 |
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| Contacts: Details of manufacturer contacts and MHRA contacts for technical and clinical aspects. Change of address or removal from address list for CSCI and Healthcare Commission. |
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| Appendix: Safety information sheet (in pdf only). |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 22 December 2006
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Deadline (action complete): 15 March 2007
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MDA/2006/070 - LifeScan OneTouch® Ultra®, LifeScan InDuo® and LifeScan PocketScan® blood glucose meters 
