MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 BASIC

Model Number 393-800

Device Problem Misassembly During Maintenance/Repair (4054)

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

Event Date 04/24/2019

Event Type  malfunction  

Event Description

On april 23rd a radiometer representative visited the customer to carry out regular maintenance.He replaced all electrode membranes but by mistake he misplaced the glu and lac electrode.Subsequently, he performed a calibration, which passed, but he did not run qc.This maintenance was finished around 13:00h.The next day the customer measured a patient blood sample (male, (b)(6)) and got a high result for cglu of >300mg/dl.Due to the high result, the patient was treated with an oral hypoglycemic agent.The measurement value from abl800 did not fall and therefore the customer did a new measurement on a third part analyzer.This result indicated that the value of cglu from abl800 was wrong.The customer checked the abl800 and noticed that glu and lac electrodes were installed in reverse.The customer placed the electrode correctly around 10:00h and after that the values from abl800 were as expected.There was no change in the patient's health.

• Brand Name: ABL800 BASIC
• Type of Device: ABL800 BASIC
• 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: 8598412
• MDR Text Key: 146362189
• Report Number: 3002807968-2019-00017
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2012
• 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: 80 YR