MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX PLUS

Model Number 393-092

Device Problem High Readings (2459)

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

Event Date 11/18/2022

Event Type  malfunction  

Event Description

According to the complaint on (b)(6) 2022, when the customer measured a patient arterial blood, the result of po2 and k+ were higher than expected.Therefore, after about an hour, they took arterial blood from the patient and measured again, both of second results were expected values.1st results: (b)(6) 2022 8:03 sample #(b)(6) po2; 197 mmhg, k+; 6.6 mmol/l, 2nd results: (b)(6) 2022 9:24 sample #(b)(6) po2; 84.4 mmhg, k+; 4.1 mmol/l.Based on performed measurements the customer considers the 1st results of po2 and k+ as false high.

Manufacturer Narrative

Radiometer investigation of the received datalogs has concluded that the cause of the reported false high po2 and k+ measurement was due to incorrect sample handling by the user of the abl90 flex plus analyzer.The abl90 flex plus analyzer measured the samples correctly and did not malfunction.Hence, the event is no longer considered reportable.

• Brand Name: ABL90 FLEX PLUS
• Type of Device: ABL90 FLEX PLUS
• 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: anders nørregaard ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 15892496
• MDR Text Key: 307738467
• Report Number: 3002807968-2022-00038
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693930923
• UDI-Public: (01)05700693930923(10)R0310N005
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160153
• 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: 12/21/2022

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: 393-092
• Device Catalogue Number: 393-092
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 12/21/2022
• 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: 70 YR
• Patient Sex: Female