ABL700 SERIES
Received Sep 15, 2006 · Event occurred Aug 16, 2006
Report 3002807968-2006-00039 · MDR key 871033
Device
Generic name
Abl700
Manufacturer
Radiometer Medical ApsModel number
ABL735Catalog number
393-735
Lot number
NA
Product problems
- Low Test Results
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
TWO CAPILLARY SAMPLES WERE TAKEN ON A NEONATE. THE FIRST SAMPLE WAS ANALYZED ON AN ABL735 BLOOD GAS ANALYZER INDICATING HB 6.3 MMOL/L. ACCORDING TO THE QC LOGS, THE DEVICE HAS PERFORMED ACCORDING TO SPECIFICATIONS. AS THE MEDICAL STAFF CONSIDERED THE VALUE TOO LOW ACCORDING TO THE PT'S CONDITION, A NEW MEASUREMENT WAS CONDUCTED. THE REFERENCE MEASUREMENT ANALYZED ON AN OTHER BLOOD GAS ANALYZER CONFIRMED THAT THE VALUE WAS HIGHER. THE SECOND OF THE ORIGINALLY TAKEN SAMPLES CONFIRMED THE HIGHER VALUE AS 9.4 MMOL/L.
Additional Manufacturer Narrative
STILL UNDER INVESTIGATION.
Remedial action
- Other