MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX PLUS ANALYZER

Model Number 393-092

Device Problem False Negative Result (1225)

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

Event Date 02/15/2023

Event Type  malfunction  

Event Description

On the 15feb2023, the customer contacted radiometer because the results of several samples on the abl90 flex plus analyzer (serial number: (b)(4) in the neonatal intensive care unit (nicu) for the ionic calcium and bilirubin were not in accordance with the clinical state of the patient.Patient 1) (b)(6): 1.12mmol/l, (b)(6): 4.7mg/dl; patient 2) (b)(6): 1.09mmol/l, (b)(6): 2.9mg/dl; patient 3) (b)(6): 1.25mmol/l, (b)(6): 7.8mg/dl.The samples were repeated on the abl90 flex plus analyzer (serial number: (b)(4)) in the lab and the results were significantly different.The abl90 flex plus analyzer in the nicu was checked by the customer and they mentioned that the calibration and quality controls for the parameters during sample measurement were within range.The customer is reporting the discrepant ionic calcium and bilirubin measurements from the abl90 flex plus analyzer in the nicu as false low.Radiometer field service engineer provided an update on 22feb2023: the customer complained again about the issue but is unable to provide discrepant and comparison measurements.The field service engineer checked the abl90 flex plus analyzer and discovered that even though the calibration and qc seems okay, some of the samples had the error message "1070 sensor response error".He replaced the sensor interface and tested 3 samples (not the same as above) and the results matched.

Manufacturer Narrative

Investigation is finalized, with the conclusion that the product did not malfunction, hence the incident is no longer considered reportable.

• Brand Name: ABL90 FLEX PLUS ANALYZER
• Type of Device: ABL90 FLEX PLUS 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: pearlyn pah ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 16477369
• MDR Text Key: 310868728
• Report Number: 3002807968-2023-00005
• Device Sequence Number: 1
• Product Code: MQM
• UDI-Device Identifier: 05700693930923
• UDI-Public: (01)05700693930923(10)R0419N024
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

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: 02/16/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• 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