G8
Received Feb 13, 2020 · Event occurred Jan 15, 2020
Report 8031673-2020-00020 · MDR key 9706392
Device
Product problems
- Output Problem
- Output Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. FSE ARRIVED AT THE SITE TO ADDRESS THE REPORTED EVENT. FSE WAS UNABLE TO CONFIRM OR REPRODUCE ANY ERRORS. FSE REMOVED THE COLUMN, FLUSHED THE SYSTEM WITH 15% BLEACH SOLUTION & DI WATER, PRIMED THE SYSTEM, AND PERFORMED PRECISION AND QUALITY CONTROL (QC) PROTOCOL, ALL RESULTS WERE WITHIN ACCEPTABLE RANGES. OF, NOTE, FSE PERFORMED PM DURING THE SAME VISIT. NO FURTHER ISSUES WERE NOTED. NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. A 13-MONTH COMPLAINT SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2018 THROUGH AWARE DATE (B)(6) 2020. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE REVIEW PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 5- MAINTENANCE STATES THE FOLLOWING: 5.1 DAILY CARE: USE A CLOTH DAMPENED WITH A NEUTRAL CLEANER TO WIPE STAINS FROM THE ANALYZER'S PLASTIC COMPONENTS ON THE FRONT SIDE (NEEDLE COVER, ETC.). DO NOT USE ORGANIC SOLVENTS SUCH AS ETHANOL TO CLEAN THE PLASTIC COMPONENTS. USE A CLOTH DAMPENED WITH A NEUTRAL CLEANER TO WIPE BLOTS AND STAINS ON METALLIC COMPONENTS AS WELL. IF CONTAMINATION IS SEVERE, WIPE USING A CLOTH SOAKED IN ETHANOL. WATER REMAINING ON METALLIC SURFACES WILL CAUSE RUST. LIGHTLY WIPE AWAY BLOTS AND STAINS ON THE SAMPLE LOADER BELT, DISPLAY, AND KEY SHEET WITH A CLOTH SOAKED IN ETHANOL. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO THE INSTRUMENT REQUIRING MAINTENANCE.
Description of Event or Problem
THE CUSTOMER REPORTED RECEIVING HIGH BIAS ON THE COLLEGE OF AMERICAN PATHOLOGISTS (CAP) SURVEY FOR THEIR G8 ANALYZER. THE CUSTOMER STATED THAT THEY FAILED ONE HEMOGLOBIN A1C (HBA1C) SAMPLE IN THE SURVEY, GH-10 10.2; WHICH HAD A RANGE OF 8.9-10.1. ALL THE OTHER SAMPLES WERE AT THE TOP OF THE RANGE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.