MAUDE MDR 707089

MDR report key
707089
Report number
3002807968-2006-00026
Event key
0
Event type
3
Date of event
2006-04-05
Date received
2006-04-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
LISE-LOTTE RINGBY
Address
AKANDEVEJ 21 BRONSHOJ DK-27 DA
Phone
827-827-8273
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ABL700 AND 800 SERIES/RADIANCEBLOOD GAS ANALYZER/RADIANCERADIOMETER MEDICAL APSCCEABL 725393-725*NRY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-04-2601. D

Event Narratives#

D

Patient 1

A BLOOD GAS ANALYSIS WERE MADE ON A ABL725 BLOOD GAS ANALYZER. THE ABL 725 SHOWED A GLUCOSE VALUE ON APPROXIMATELY 320 MG/DL (17,8 MMOL/L). A MEASUREMENT REPORT PRINTED FROM A COMPUTER WITH THE SOFTWARE RADIANCE, SHOWED A VALUE OF APPROXIMATELY 18 'MG/DL' (HOWEVER, THE CORRECT UNIT AND THE READ OUT OF THE ABL725 WAS CORRECT IN MMOL/L). THE INTERPRETATION OF THE REPORT SHOWING THE 18 'MG/DL' (WRONG UNIT) WAS CLINICALLY INTERPRETED AS VERY LOW. THIS RADIANCE REPORT VALUE OF 18 'MG/DL' WITH AN ACTUAL CORRECT UNIT IN MMOL/L ON THE ABL725 PRINTOUT WAS USED FOR THE DIAGNOSE OF THE PATIENT, AND THE PATIENT WERE TREATED WITH MEDICATION (PROBABLY GIVEN GLUCOSE I.V.) TO GET THE GLUCOSE TO RISE. THE CORRECT VALUE WAS 330 MG/DL OR THE 18,3 MMOL/L PRINTOUT OF THE ABL725. THE PROBLEM IS RELATED TO THE REPORT PRINTOUT LAYOUT IN THE RADIANCE SYSTEM. IF THE DEFAULT -R- LAYOUT IS USED, THE UNITS WILL BE TAKEN FROM THE DATABASE AND ACTUAL VALUE AND UNITS WILL MATCH. IT IS, HOWEVER, POSSIBLE TO HARD CODE THE UNITS ON THE REPORT FORM, WHICH WAS DONE IN THIS CASE.