MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX ANALYZER

Model Number 393-800

Device Problem Patient Data Problem (3197)

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

Event Date 06/06/2020

Event Type  malfunction  

Manufacturer Narrative

Health professional: no information.

Event Description

According to the customer, the abl800 flex (i902-754r1296n0004) performed wrong readings of the barcode, which consequently resulted in patient date mix-up.At 8:37 am, a sample was introduced in the abl805 (patient (b)(6)), while the analysis was taking place on the equipment, they called from the secretariat to say that patient (b)(6) was about to enter for collection, but in the system the sample was already being processed.This would be impossible because the patient had not even had the sample collected yet.When they went to see the equipment, the patient was wrongly identified, that is, the barcode reader read (b)(6) when it should have read (b)(6).

Manufacturer Narrative

D5 has been filled out with health prof.As the received information has been reevaluated.G3: corrected data: aware date was originally estimated in mdr initial, as it was unknown.Originator has since then updated aware date to 23jun2020.As the aware date update was requested 20aug2020, this has been filled out in g3 in mdr follow up.

Manufacturer Narrative

The investigation for this event has been finalized.From the investigation of the data logs and the available information it has been concluded that the incident with data mix-up occured because of misreading of barcodes.Customer was using interleaved 2 of 5.The root has been identified as "use of barcodetype without a check degit".

• Brand Name: ABL800 FLEX ANALYZER
• Type of Device: ABL800 FLEX ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 10232548
• MDR Text Key: 203335363
• Report Number: 3002807968-2020-00027
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K041874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393-800
• Device Catalogue Number: 393-800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1