MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number	393-801
Medical Device Problem Codes	Incorrect Measurement (1383); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer replaced the affected analyzer at the hospital with an alternative analyzer.
Event or Problem Description
On (b)(6) 2019, a crea measurement measured on an abl801 was within the normal range and the patient was provided contrast agent for an image diagnosis.However, the patient originally had a poor kidney function.The doctor confirmed that the taken contrast agent did not damage the patient.The patient has not received any damage and any treatment based on the contrast agent.A measurement of 0.9 mg/dl was measured on the abl801 and a comparison measurement in the laboratory gave 3.5 mg/dl.However, all levels of quality controls (qcs) had been used, despite that customers has been instructed to narrow the range and use qc level 1.Furthermore, the alert for qc out of range was not set.
Additional Manufacturer Narrative
The measurement error was caused by a failing crea membrane.The customer had not followed the recommended procedure for quality controls for measurements of crea.Furthermore, there was found a underlying instability if the crea electrode, which was not detected as the customer had disabled the alarms.

• Brand Name: ABL800 FLEX
• Common Device Name: ABL800 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 8743305
• Report Number: 3002807968-2019-00028
• Device Sequence Number: 16625783
• Product Code: JFP
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R1324N007
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

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?: Yes
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1