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 12/16/2021

Event Type  malfunction  

Manufacturer Narrative

All three abl90 flex analyzers in the operating room show backlog errors.The field service engineer took samples that were measured in the laboratory and measured them on one of these three abl90 flex analyzers (09r1040n053).After each measurement he had a cal backlog error and k+, na+ and ca2+ were all too low compared to the laboratory.He took out the sensor cassette (sc), cleaned the ref contacts, ran a calibration and still had results that were too low compared to the laboratory.All qc levels were fine.He then took this sc and placed it into another analyzer which measured fine before (09r1040n051).Apparently, the sc carried the errors to the other analyzer.The good sc from abl90, 09r1040n051 also worked fine in abl90, 09r1040n053.Data logs have been sent to radiometer medical for investigation.

Event Description

The customer complains about implausible results for electrolytes and ph on a abl90 flex analyzer.Calibration backlog error is also shown.Original measurement (090r1036n019): ck+: 2,9 & 2,9 mmol/l, cna+: 124 & 128 mmol/l, cca2+: 1,01 0,97 mmol/l, ccl-: 104 & 109 mmol/l, ph: 7,414 & 7,441 mmol/l.Comparison measurements abl90 (two other abl90 flex analyzers): ck+: 4,4 & 4,4 mmol/l, cna+: 139 & 140 mmol/l, cca2+: 1,22 & 1,22 mmol/l, ccl-: 106 & 106 mmol/l, ph: 7,405 & 7,412.Comparison measurement (cobas 8000) units are only an assumption since they are not shown on the printout: k: 4,53 mmol/l, na: 138,1 mmol/l , ca2: 2,35 mmol/l, cl: 104,0 mmol/l.The abl90 flex analyzer (090r1036n019) which this complaint is about, has been moved to the laboratory.A replacement analyzer was set up at the operating room / anesthetic recovery room.Calibration backlog error is also shown for two other abl90 flex analyzers in the operating room.The customer owns more than 20 analyzers and according to the customer only these three show up with errors.There has been no harm to patients.

Manufacturer Narrative

The investigation strongly suggest contamination of sensors as root cause.An example could be cleaning procedure with use of wipes containing surface active substances such as benzalkonium chloride.Such surface active substances damage the sensors with the effect being accumulated over time.Only cleaning and maintenance procedures specified in instruction for use (ifu) are to be used.Investigation is still not closed as radiometer is awaiting feedback from the customer regarding their cleaning procedures.

• 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: tom engdahl ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 13257700
• MDR Text Key: 295250806
• Report Number: 3002807968-2022-00001
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R1036N019
• 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,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• 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