VERITI DX THERMAL CYCLER
Received Apr 21, 2014 · Event occurred Mar 4, 2014
Report 3003673482-2014-00008 · MDR key 3855695
Device
Generic name
Thermocycler, Generic
Manufacturer
Life Technologies Holdings Pte. Ltd.Catalog number
4452300
Lot number
299120264
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INSTRUMENT WAS RETURNED TO LIFE TECHNOLOGIES CORP AND REPAIRED BY REPLACING POWER AMPLIFIER & DAMPER. AFTER REPAIR, THE INSTRUMENT PASSED ALL THE CALIBRATION, FINAL TESTS, PERFORMANCE SPECIFICATIONS. THE INSTRUMENT WAS SENT BACK TO THE CUSTOMER. THE DEVICE WAS USED AS A DIAGNOSTIC. DEVICE INTENDED USE CAN BE FOUND ON PAGE 3 OTHER REMARKS. DEVICE INTENDED USE: THE APPLIED BIOSYSTEMS VERITI DX THERMAL CYCLER AMPLIFIES HUMAN NUCLEIC ACID SAMPLES FOR DIAGNOSTIC APPLICATIONS. THE VERITI DX THERMAL CYCLER IS TO BE USED ONLY BY OPERATORS TRAINED IN LAB TECHNIQUES AND PROCEDURES.
Description of Event or Problem
A CUSTOMER REPORTED A PROBLEM OF AN EXCEEDED MAXIMUM HOLD UNDERSHOOT COMING FROM VERITI DX THERMAL CYCLER (CAT NO. 4452300, SERIAL NO. (B)(4)). THIS CAUSES THE INSTRUMENT TO STOP IN THE MIDDLE OF A RUN. NO PT INVOLVEMENT REPORTED. THE COMPANY EVENT TRACKING NO. IS (B)(4).
Remedial action
- Repair