FDA Adverse Event Malfunction Summary report: N

ABL800 FLEX

MDR report key: 8743305 · Received June 28, 2019

Report

Report Number: 3002807968-2019-00028
Event Type: Malfunction
Date Received: June 28, 2019
Date of Event: June 13, 2019
Report Date: May 19, 2020
Manufacturer: RADIOMETER MEDICAL APS
Product Code: JFP
UDI-DI: 05700693938011
PMA / PMN Number: K041874
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

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 · 1

A FIELD SERVICE ENGINEER REPLACED THE AFFECTED ANALYZER AT THE HOSPITAL WITH AN ALTERNATIVE ANALYZER.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
536569	ABL800 FLEX	ABL800 FLEX	JFP	RADIOMETER MEDICAL APS	393-801		05700693938011

Patients

Seq	Age	Sex	Outcome	Treatment
1