MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER; ABL90 FLEX ANALYZER, PRODUCT CODE CHL

Model Number 393-090

Device Problems Insufficient Information (3190); Patient Data Problem (3197)

Patient Problem No Patient Involvement (2645)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

This case is related to 3002807968-2019-00031 with patient identifier (b)(6).

Event Description

According to the complaint, a customer experienced retransmission of patient data with wrong times and dates in the neonatal ward.According to the customer, this was done spontaneously without any intervention of the medical staff.Patient a: blood gas results done on june 28th at 8:02 were re transmitted into patient file on july 3rd at 3:07 and 3:08 am patient b: blood gas results done on july 1st at 9:01 am were re transmitted into patient file on july 3rd at 3:14 the hospital decided to disconnect the abl 90 from the hospital net.

Manufacturer Narrative

It has come to radiometer medicals attention that the udi code and the information in g7 were wrong.In the initial report "initial" in section g7 should have been ticked off.The udi code has been corrected in this report.Radiometer has not been able to acquire the requested data from the customer and therefore no investigation was performed.Radiometer considers this case closed.

• Brand Name: ABL90 FLEX ANALYZER
• Type of Device: ABL90 FLEX ANALYZER, PRODUCT CODE CHL
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej 2700, da,
• MDR Report Key: 8802279
• MDR Text Key: 207738616
• Report Number: 3002807968-2019-00030
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909
• Combination Product (y/n): N
• PMA/PMN Number: K092686
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 393-090
• Device Catalogue Number: 393-090
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1