ABL700 ABL735 393-725

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2006-07-17 for ABL700 ABL735 393-725 manufactured by Radiometer Medical Aps.

Event Text Entries

[490027] A too low na-value was measured on an abl735 blood gas analyzer. No alarm was issued. The low na value may have been caused by a defective reference electrode. Allegedly 4 or 5 patients were inappropriately treated for too low na values in the bloodstream. No serious injury or death has been reported as a consequence of these treatments.
Patient Sequence No: 1, Text Type: D, B5


[7794184] The hospital alleges the reference membrane is drifting after 4 or 5 days. Additional tests are undertaken.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3002807968-2006-00036
MDR Report Key743489
Report Source01
Date Received2006-07-17
Date of Report2006-07-14
Date of Event2006-06-16
Date Added to Maude2006-08-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactPIERRE PELLETIER
Manufacturer StreetAKANDEVEJ 21
Manufacturer CityBRONSHOJ DK-2700
Manufacturer CountryDA
Manufacturer PostalDK-2700
Manufacturer Phone8273614
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameABL700
Generic NameBLOOD GAS ANALYZER
Product CodeCCE
Date Received2006-07-17
Model NumberABL735
Catalog Number393-725
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key731285
ManufacturerRADIOMETER MEDICAL APS
Manufacturer AddressAKANDEVEJ 21 BRONSHOJ DA DK-2700


Patients

Patient NumberTreatmentOutcomeDate
10 2006-07-17

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