MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX PLUS

Model Number 393-092

Device Problems Optical Problem (3001); Output Problem (3005); Patient Data Problem (3197)

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

Event Date 01/17/2022

Event Type  malfunction  

Event Description

According to the complaint, the analyzer's barcode reader misinterprets the patient barcode information.When the customer scans the patient barcode, the analyzer's scanner changes one of the letter or numbers (mostly the middle character) to a different character so the patient information will potentially match a different patient information.For example: " the sample id was (b)(6) but it scanned as (b)(6) and went to the batched and matched up to a different patient.This is the issue we were having since we started using this new analyzer".The customer tried the same barcode was interpreted with abl90 flex plus on the abl90 flex analyzer beside of it and it never happened.

Manufacturer Narrative

Investigator requested the misreading barcode reader returned at 27-01-2022 without any luck as it seems not to be available.The photo from the case shows that the customer uses a barcode which is identified as code 39.'eh955169' was read as 'eh955a69'.Radiometer estimate that the barcode reader fault is due to a hardware failure (dirt or scan engine failures) which due to missing receiving of the defective barcode reader cannot be investigated further.As the customer continuing uses a barcode without check digit, read failures may occur in the future, so the customer may consider changing barcode type.In the ifu for abl90 flex chapter "getting to know the analyzer" "common tasks" "to scan a barcode": note : radiometer recommends using barcodes with a check digit to avoid the risk of misreading.The barcode scanner at customer replaced.Use of a barcode format with check sum recommended.

• 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: tom engdahl ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 13514212
• MDR Text Key: 296309137
• Report Number: 3002807968-2022-00007
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693930923
• UDI-Public: (01)05700693930923(10)R0275N013
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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