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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-10-08-25-993
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
t:slim X2 Insulin Pump
الأجهزة المتأثرة
t:slim X2 Insulin Pump
الممثل المعتمد
Bio Standards LLC
سبب المشكلة
Tandem has identified certain speaker versions that have a higher rate of Malfunction 16 events due to a wiring issue within the speaker.
الإجراء التصحيحي
Customers are to: 1. If you haven’t had a Malfunction 16, continue using your Tandem pump as described in the User Guide, but with added precautions because the Malfunction 16 can occur at any time. 2. If you are using a Dexcom sensor, use the Dexcom mobile app as a secondary means of CGM alerts and alarms. 3. If you receive a Malfunction 16 alert: a. Promptly acknowledge it by pressing “Silence Alarm”. b. Contact your distributor to report the malfunction. c. Switch to your backup method of insulin delivery as directed by your physician. 4. Regularly check your blood sugar to ensure you are not having unexpectedly high or low readings. 5. Be prepared with a backup method of insulin delivery as directed by your physician, as set forth in the pump training, and as laid out in the pump user guide. 6. Software update to improve detection & add vibration alerts will be released; distributor will notify when ready. Manufacturer action: Instructions and Correction.
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