MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number 393-801

Device Problem Insufficient Information (3190)

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

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

Health professional should be no information.

Event Description

According to the complaint, a customer from a neonatal icu reports that an abl827 flex analyzer (754r0313n001) gave spurious results for the na+, ica2+ and to a lesser extent k+ parameter.The spurious results were obtained from 6 different patients that gave the following results: sample #: k+ 5.1, ca++ 1.33.Sample # (b)(6): na 148, ca 1.65.Sample # (b)(6): na 153, ca1.52.Sample # (b)(6): na 148, k 5.1, ca 1.43.Sample# (b)(6): k 5.5, ca 1.33.Sample # (b)(6): na 149, k 5.4, ca 1.55.The customer reports that the measured results did not correlate with the clinical status of the patients.Assuming all patients should be in normal range for the na, ca and k parameter it is assed that in a worst case scenario the discrepancies could lead to harm for the patients.None of the patients were impacted or injured due to this event.Patients are still on hospital ward undergoing ongoing treatment.No additional treatment were required as a consequence of this event.

Manufacturer Narrative

This case is related to the same analyzer as in 3002807968-2020-00002 from which the data logs have been received.

Manufacturer Narrative

From the preliminary radiometer investigation it was found that the discrepant results were most likely due to the use of non-radiometer samplers.However, since the hospital solved the issue by replacing the abl800 flex with an abl90 flex analyser, radiometer can not obtain evidence for this and the root cause remains unknown.

• Brand Name: ABL800 FLEX
• Type of Device: ABL800 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 9509203
• MDR Text Key: 219848875
• Report Number: 3002807968-2019-00062
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R0313N001
• 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,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Date Manufacturer Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1