التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

• Please review the attachment with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.
• Manually dilute patient samples that are > 18.00 mg/L:
1. Navigate to the CH Test Definition screen.
2. Under Measuring Interval, uncheck “Repeat when Outside Measuring Interval.”
3. For samples that generate test results > 18.00 mg/L, prepare a 1:2 manual dilution with saline solution (0.9% unbuffered Isotonic saline).
4. From the Create Patient Order screen, order the sample and enter “2” in the manual dilution field on the left of the screen.
Note: The system will apply the 1:2 dilution factor and calculate the final result.
5. Process the manually diluted sample.
6. Report results greater than 36.00 mg/L as “>36.00 mg/L.”
The Atellica CH B2M assay IFU will be updated with the above steps to support manual 1:2 dilution only with saline for samples > 18.00 mg/L. Please see Appendix in the attachment, Table 2, for data using these revised instructions.

Manufacturer Action: Instructions and Correction.

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-06-11-24-664