FDA Adverse Event Malfunction Summary report: N

VERITI DX THERMAL CYCLER

MDR report key: 3855695 · Received April 21, 2014

Report

Report Number: 3003673482-2014-00008
Event Type: Malfunction
Date Received: April 21, 2014
Date of Event: March 4, 2014
Report Date: March 4, 2014
Manufacturer: LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Product Code: OUL
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

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 · 1

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).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
241666	VERITI DX THERMAL CYCLER	THERMOCYCLER, GENERIC	OUL	LIFE TECHNOLOGIES HOLDINGS PTE. LTD.		299120264

Patients

Seq	Age	Sex	Outcome	Treatment
1