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 08/05/2021

Event Type  malfunction  

Event Description

According to the complaint the customer considers ph results from (b)(6) 2021 as false high compared to comparison measurements: "our recent rcpa failed for theatre b with a higher-than-expected ph for both samples.Looking at the patient results around this time there was a bypass patient tested just before and again after.Bypass sample just prior to our rcpa samples was 7.412, whilst bypass samples from same patient later in the day had lower ph.Rcpa measurements were sampled at 11:34 and 11:36.There were repeated ph back log errors during 09:12 to 11:36.The activity logs show a cleaning and no clots detected after each ph back log.No calibration failures.Improved clot detection is enabled.No other messages or prompts for clot detected or full calibration initiated by analyser.Scheduled qc was run at 13:02 which was after issues cleared.There were 3 x ph measurements on 5/8/21 that are considered discrepant based on comparison measurements: at 11:34 an rcpa (eqa) sample gave a result of 7.27 compared to a peer result median 7.14 (alp 7.10 - 7.18) at 11:36 an rcpa (eqa) sample gave a result of 7.40 compared to a peer result median 7.32 (alp 7.28 - 7.36) at 11:26 an patient sample gave a result of 7.412 compared to a previous result 7.312 during this time there were also a number of backlog errors 09:12, 10:31, 11:02, 11:36 at 11:44 there was an operator initiated (automatic flush) cleaning cycle - this is standard practice following the rcpa cooximetry sample measurement (the coox samples are lyophilised whole blood) this appears to have resolved the backlog errors.

Manufacturer Narrative

Radiometer investigation of the event has identified that a likely explanation is that a blood clot is lodged in the sensor cassette in the vicinity of the ph-sensor.An operator initiated (automatic flush) cleaning cycle was completed, and the problem was not observed afterwards.

Event Description

Additional information received 08sep2019: the customer considers the following measurements as false high (discrepant) and comparisons (not discrepant): sample: measurement time: parameter: result: discrepant comparison patient id: time measurement: measurement: (b)(6), 5/8-21; 10:31; ph: 7.319; x; 5/8-21; 11:24; ph: 7.412; x; 5/8-21; 12:22; ph: 7.346; x.

• Brand Name: ABL90 FLEX PLUS
• Type of Device: ABL90 FLEX PLUS
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 12431483
• MDR Text Key: 270072041
• Report Number: 3002807968-2021-00035
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693930923
• UDI-Public: (01)05700693930923(10)R0225N025
• Combination Product (y/n): N
• PMA/PMN Number: K160153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• 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
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR