MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX ANALYZER

Model Number 393-801

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

Since the unstable calibrations is an on-off issue this indicates that the unstable calibrations are due to a problem with the analyzer and not the membrane unit itself.

Event Description

According to the complaint, a customer obtained the following creatinine results applying the abl800 flex analyzer: (b)(6) 2018/ 11:47h / analyzer serial number (b)(4)/ 0.91 mg/dl / membrane lot r824.At 12:40h at 2018-12-12, the customer changed creatinine membranes, which was the first time since 2018-11-29 at 14:51h.Subsequently, the venous creatinine result was: (b)(6) 2018/ 12:40h/ analyzer serial number (b)(4)/ 4.28 mg/dl /membrane lot r832.Based on the series of measurements, the customer reports the result of 0.91 mg/dl as false low.

• Brand Name: ABL800 FLEX ANALYZER
• Type of Device: ABL800 FLEX ANALYZER
• 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: bolette duun-christensen ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 8188732
• MDR Text Key: 131929417
• Report Number: 3002807968-2018-00068
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754754R2063N005
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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: 12/14/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2015
• 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