ABL800 FLEX
Received Jun 28, 2019 · Event occurred Jun 13, 2019
Report 3002807968-2019-00028 · MDR key 8743305
Device
Product problems
- Incorrect Measurement
- Insufficient Device Problem Information
- Incorrect Measurement
- Insufficient Device Problem Information
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE MEASUREMENT ERROR WAS CAUSED BY A FAILING CREA MEMBRANE. THE CUSTOMER HAD NOT FOLLOWED THE RECOMMENDED PROCEDURE FOR QUALITY CONTROLS FOR MEASUREMENTS OF CREA. FURTHERMORE, THERE WAS FOUND A UNDERLYING INSTABILITY IF THE CREA ELECTRODE, WHICH WAS NOT DETECTED AS THE CUSTOMER HAD DISABLED THE ALARMS.
Additional Manufacturer Narrative
A FIELD SERVICE ENGINEER REPLACED THE AFFECTED ANALYZER AT THE HOSPITAL WITH AN ALTERNATIVE ANALYZER.
Description of Event or Problem
ON (B)(6) 2019, A CREA MEASUREMENT MEASURED ON AN ABL801 WAS WITHIN THE NORMAL RANGE AND THE PATIENT WAS PROVIDED CONTRAST AGENT FOR AN IMAGE DIAGNOSIS. HOWEVER, THE PATIENT ORIGINALLY HAD A POOR KIDNEY FUNCTION. THE DOCTOR CONFIRMED THAT THE TAKEN CONTRAST AGENT DID NOT DAMAGE THE PATIENT. THE PATIENT HAS NOT RECEIVED ANY DAMAGE AND ANY TREATMENT BASED ON THE CONTRAST AGENT. A MEASUREMENT OF 0.9 MG/DL WAS MEASURED ON THE ABL801 AND A COMPARISON MEASUREMENT IN THE LABORATORY GAVE 3.5 MG/DL. HOWEVER, ALL LEVELS OF QUALITY CONTROLS (QCS) HAD BEEN USED, DESPITE THAT CUSTOMERS HAS BEEN INSTRUCTED TO NARROW THE RANGE AND USE QC LEVEL 1. FURTHERMORE, THE ALERT FOR QC OUT OF RANGE WAS NOT SET.