MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number 393-800

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problem Hyperbilirubinemia (1903)

Event Date 05/31/2018

Event Type  Injury  

Event Description

According to the complaint, a customer obtained a bilirubin result of 2.0 mg/dl on a neonate.From a comparison method applying architect 200, however with no data available, the concentration of bilirubin was reported to be approximately 11 mg/dl.

Manufacturer Narrative

Root cause for the issue is that hbf correction was disabled by the customer, even though it is stated in operator's manual that it should be enabled while conducting neonatal analyses.Neither death or serious injury have been reported.From the initial version of the existing event, malfunction was chosen as type of reportable event.However, as it is a matter of use error, no type of reportable event could be ticked off.

Manufacturer Narrative

By mistake, in 3002807968-2018-00043 follow-up 1 it was stated that no serious injury happened.Conclusively, the existing matter is a serious injury together with the fact that root cause for the issue was that hbf correction was disabled by the customer.

• Brand Name: ABL800 FLEX
• Type of Device: ABL800 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 7618130
• MDR Text Key: 111762558
• Report Number: 3002807968-2018-00043
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754754R1939N006
• Combination Product (y/n): N
• PMA/PMN Number: K043218
• 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: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393-800
• Device Catalogue Number: 393-800
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization