MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX

Model Number 393-090

Device Problem Low Readings (2460)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2022

Event Type  malfunction  

Event Description

According to the complaint, on (b)(6) 2022, measurement results for potassium (k+) appeared to be slightly lower in comparison to the results measured by other abls at the same hospital.The discrepant measurement was 2.8 mmol/l and the comparison measurement was 3.4 mmol/l.No reports of death or serious injury.

Manufacturer Narrative

Analysis supports cl parameter ok and that increasing errors on na, k, ca and ph blood measurements as a function of in-use lifetime is seen.In addition, analysis supports the complaint information that the problems are restricted to the operating room / anesthetic recovery room setting.Summing up analysis for this complaint strongly suggest contamination of sensors as root cause.Only cleaning and maintenance procedures specified in instruction for use (ifu) are to be performed.It is suggested to customer to avoid use of any type of cleaning wipes for cleaning analyzer inlet etc.As they may contain surface active substances which damage the sensors.

• Brand Name: ABL90 FLEX
• Type of Device: ABL90 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: christoffer thaysen ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 13366011
• MDR Text Key: 295605118
• Report Number: 3002807968-2022-00004
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R1039N041
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K092686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393-090
• Device Catalogue Number: 393-090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 01/27/2022
• Supplement Dates Manufacturer Received: 02/24/2022
• Supplement Dates FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1