MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX

Model Number 393-090

Device Problem High Readings (2459)

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

Event Date 10/24/2022

Event Type  malfunction  

Event Description

According to the complaint, a patient blood sample of a child was run on the abl90 flex analyzer with the following result for blood glucose: 22mmol/l.The measurement was not in line with the patient's condition, so they re-measured the blood sugar (by the heel of the child) to be 3.5mmol/l, the operator immediately contacted the engineer of the manufacturer and put a temporary status card on the device.Based on the two measurements, the first result was reported as false high by the customer.

Manufacturer Narrative

Information was received that the nurse had not payed attention to an error message of the glu item, and still used the analyzer to test.As such the analyzer worked as intended, and the incident is no longer considered reportable.

• Brand Name: ABL90 FLEX
• Type of Device: ABL90 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer Contact: cecilie jensen ; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 15742391
• MDR Text Key: 303162534
• Report Number: 3002807968-2022-00037
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• 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: 10/24/2022
• 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
• Patient Age: 24 DA
• Patient Sex: Male