MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number 393-801

Device Problems Incorrect Measurement (1383); Insufficient Information (3190)

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

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer replaced the affected analyzer at the hospital with an alternative analyzer.

Event Description

On (b)(6) 2019, a crea measurement measured on an abl801 was within the normal range and the patient was provided contrast agent for an image diagnosis.However, the patient originally had a poor kidney function.The doctor confirmed that the taken contrast agent did not damage the patient.The patient has not received any damage and any treatment based on the contrast agent.A measurement of 0.9 mg/dl was measured on the abl801 and a comparison measurement in the laboratory gave 3.5 mg/dl.However, all levels of quality controls (qcs) had been used, despite that customers has been instructed to narrow the range and use qc level 1.Furthermore, the alert for qc out of range was not set.

Manufacturer Narrative

The measurement error was caused by a failing crea membrane.The customer had not followed the recommended procedure for quality controls for measurements of crea.Furthermore, there was found a underlying instability if the crea electrode, which was not detected as the customer had disabled the alarms.

• Brand Name: ABL800 FLEX
• Type of Device: ABL800 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 8743305
• MDR Text Key: 149945347
• Report Number: 3002807968-2019-00028
• Device Sequence Number: 1
• Product Code: JFP
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R1324N007
• 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
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 393-801
• Device Catalogue Number: 393-801
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1