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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX ANALYZER; ABL800 FLEX ANALYZER WITH CREA MODULE
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RADIOMETER MEDICAL APS ABL800 FLEX ANALYZER; ABL800 FLEX ANALYZER WITH CREA MODULE Back to Search Results
Model Number 393-801
Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event is best guess.
 
Event Description
According to the complaint, a customer reports false creatinine results applying abl837 analyzer.From a comparison test, comparing creatinine results from cobas (roche) with those from abl837 analyzer demonstrate that creatinine concentration as determined on abl837 could be ~25% lower than on cobas.
 
Manufacturer Narrative
From a capa related to (b)(4), it has been decided to increase lower limit for ac6+l1 (quality control) with 20 microm to reduce risk of low creatinine measurements.The final conclusion will be included in (b)(4).
 
Manufacturer Narrative
Correction/removal reporting number is yet to be determined.Internal radiometer reference is fan (b)(6) and crr was submitted july 2nd 2018.
 
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Brand Name
ABL800 FLEX ANALYZER
Type of Device
ABL800 FLEX ANALYZER WITH CREA MODULE
Manufacturer (Section D)
RADIOMETER MEDICAL APS
aakandevej 21
broenshoej, 2700
DA  2700
MDR Report Key7564587
MDR Text Key109903305
Report Number3002807968-2018-00042
Device Sequence Number1
Product Code CHL
Combination Product (y/n)N
PMA/PMN Number
K041874
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 07/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number393-801
Device Catalogue Number393-801
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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