MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number	393-801
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Health professional should be no information.
Event or Problem 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.
Additional Manufacturer Narrative
This case is related to the same analyzer as in 3002807968-2020-00002 from which the data logs have been received.
Additional 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
• Common Device Name: ABL800 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 9509203
• Report Number: 3002807968-2019-00062
• Device Sequence Number: 16529541
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R0313N001
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K041874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 02/14/2020; 04/14/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/21/2020; 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1