MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX PLUS ANALYZER

Model Number 393-092

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem No Code Available (3191)

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

Radiometer originally sent this report on the date stated in report date, but with an incorrect report number.This is a resubmission of the original report.

Event Description

According to the customer, the setup of the sample volume for capillary samples for the abl800 analyzer was at some point changed from 45 ul to 65 ul.This has caused a lot of samples with insufficient samples and no results.It is reported that there has been some cesareans as a result of the missing results.

Manufacturer Narrative

In usa, a customized version of the software is distributed.This version does not include the 45 l mode.Hence, the reported incident could not happen in the us.Investigation of the data logs show that the change in setup from k45 to k65 could have been done by a remote user through radiance according to the timeline listed.It could also have been done by the radiometer field service engineer (fse).It is possible to change the access rights for a remote user (except radiometer fse) not allowing these persons to access the sample setup.Since it is not possible to see when the setup was changed it isn't possible to investigate further.

Manufacturer Narrative

In the initial report, date received by manufacture, was incorrectly stated to be 04/23/2017.The correct date is 03/23/2017.

• Brand Name: ABL90 FLEX PLUS ANALYZER
• Type of Device: ABL90 FLEX PLUS
• 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 ; 538273827
• MDR Report Key: 6584322
• MDR Text Key: 75761603
• Report Number: 3002807968-2017-00013
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K160153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 393-092
• Device Catalogue Number: 393-092
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2015
• 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 Outcome(s): Required Intervention