MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number 393-090

Device Problem High Readings (2459)

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

Event Date 07/29/2022

Event Type  malfunction  

Event Description

According to the complaint, two samples was measured on a abl90 flex analyzer (b)(4) with discrepant potassium results: sample #(b)(4) on (b)(6) 2022 at 11:23am = 11.0 mmol/l.Sample #(b)(4) on (b)(6) 2022 at 11:49am = 9.0 mmol/l.Comparison measurement on another analyzer (b)(4): sample #(b)(6) on (b)(6) 2022 at 11:49 = 4.5 mmol/l.Based on the comparison measurement, the first two result were reported as false high by the customer.

Manufacturer Narrative

The radiometer root cause investigation concludes no malfunction.The most probably root cause for the high k+ level in sample is due a contaminated sample in combination with minor contribution from hemolysis of the sample or some medicine that cause interference at k+.The impact from contamination could indicate a contamination from wipes or virkon in combination with handling of the capillary without end caps.

• Brand Name: ABL90 FLEX ANALYZER
• Type of Device: ABL90 FLEX ANALYZER
• 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 ; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 15190506
• MDR Text Key: 304476128
• Report Number: 3002807968-2022-00029
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R0194N007
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• 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
• Patient Age: 5 MO
• Patient Sex: Female
• Patient Weight: 4 KG