OMNI

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER COMPLAINED OF A BURNT SMELL FROM THE COBAS B 221 INSTRUMENT. THE CUSTOMER TURNED THE SYSTEM OFF. THE FIELD SERVICE ENGINEER CHANGED THE POWER SUPPLY CORD. AFTERWARDS, THE INSTRUMENT WORKED FINE. NO ADVERSE EVENT OCCURRED. NO PATIENTS WERE AFFECTED. THE POWER SUPPLY UNIT WITH SERIAL NUMBER (B)(4) THAT WAS CONNECTED TO THE B 221 INSTRUMENT WITH SERIAL NUMBER 7116 WAS RETURNED FOR INVESTIGATION. DURING FURTHER INVESTIGATION OF THE POWER SUPPLY UNIT A BLOWN AC/DC INPUT FUSE WAS IDENTIFIED. EVIDENCE WAS PROVIDED THAT SHOWS VISIBLE SIGNS OF MELTING AND BURNING IN THE POWER SUPPLY UNIT. THE CAUSE WAS DETERMINED TO BE A DEFECTIVE VARISTOR. THE VARISTOR IS RESPONSIBLE TO LIMIT OVERVOLTAGE. IF THE ENERGY LEVEL IS TOO HIGH THE VARISTOR CAN BECOME DAMAGED AND CAUSE A SHORT CIRCUIT CAUSING A BURNING SMELL. THE RISK OF FIRE IS HIGHLY UNLIKELY. THE SURROUNDING MATERIAL IS FIRE-RETARDANT. NO SPECIFIC CAUSE FOR THE DEFECTIVE VARISTOR COULD BE IDENTIFIED. A POSSIBLE ROOT CAUSE OF THE ISSUE MAY BE A TEMPORARY FAILURE DUE TO THE AGE OF THE POWER SUPPLY ATTACHED TO THE INSTRUMENT.

Additional Manufacturer Narrative

CLARIFICATION WAS RECEIVED THAT DATE RECEIVED BY MANUFACTURER SHOULD BE 06/23/2015. ROCHE DIAGNOSTICS ACKNOWLEDGES THE UPDATE TO 06/23/2014 NOW RENDERS THE SUBMISSION OF THE INITIAL MEDICAL DEVICE REPORT OUTSIDE OF THE REQUIRED 30 DAY TIMEFRAME AS DEFINED IN 21 CFR 803.