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

Model Number 393-092

Device Problem Patient Data Problem (3197)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/22/2019

Event Type  malfunction  

Event Description

According to the complaint received, a customer reported to have intermittent patient barcode labelling issues on an abl90 flex analyzer.The following cases were observed when different patient labels were scanned: only some of the digits in the medical record number (mrn) was detected and one of the digits was incorrect.The patient name was correct.The mnr is correctly detected.But the patient name is not detected.Based on the current investigation performed in r&d, the issue seems to be related to the patient demographic rather than the reading of the barcode.New data of the issue has been requested by radiometer to perform further investigation.

Manufacturer Narrative

Based on the investigation performed it was not possible to determine the root cause in this case.The customer used a code-39 barcode, which do not have a check digit.A barcode without check digit can be misread, especially if the quality of the barcode is not good.It is reccomended that the settings of the barcode reader is changed in order to give improved reliability when reading code-39 barcodes.The next software release for abl90 flex will improve reliability when reading barcodes.

• 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
• MDR Report Key: 8572625
• MDR Text Key: 146362106
• Report Number: 3002807968-2019-00016
• Device Sequence Number: 1
• Product Code: MQM
• UDI-Device Identifier: 05700693930923
• UDI-Public: (01)05700693930923
• 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: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 393-092
• Device Catalogue Number: 393-092
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1