FDA.reportPublic FDA data

MAUDE MDR 5953351

MDR report key
5953351
Report number
1823260-2016-01384
Event key
0
Event type
3
Date of event
2016-08-14
Date received
2016-09-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
NA MICHAEL LESLIE
Address
9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US
Phone
317-317-3175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COBAS B 121BLOOD GAS ANALYZERROCHE DIAGNOSTICSJJCNAASKUNAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-150

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6).

D

Patient 1

THE CUSTOMER QUESTIONED THB RESULTS FOR 1 PATIENT TESTED ON THE ROCHE OMNI S COBAS B 221 SYSTEM AND THE COBAS B 121 SYSTEM. ALTHOUGH THE COBAS B 121 SYSTEM IS NOT SOLD IN THE UNITED STATES, THE MEASURING PRINCIPAL FOR THB ON THE COBAS B 121 SYSTEM IS SIMILAR TO THE MEASURING PRINCIPAL FOR THB ON THE COBAS B 221 SYSTEM. BASED ON THE DATA PROVIDED, ERRONEOUS THB AND HCT RESULTS WERE IDENTIFIED. THIS MEDWATCH WILL COVER THE B 121 SYSTEM. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE B 221 SYSTEM. ON (B)(6) 2016 THE THB RESULT FROM THE COBAS B 121 SYSTEM WAS 6.5 G/DL. THE RESULT FROM THE CUSTOMER'S SYSMEX SYSTEM WAS 8.6 G/DL. THE HCT RESULT FROM THE COBAS B 121 SYSTEM WAS 16.5%. THE RESULT FROM THE CUSTOMER'S SYSMEX SYSTEM WAS 23.2%. ON (B)(6) 2016 THE HCT RESULT FROM THE COBAS B 221 SYSTEM WAS 16.2%. THE RESULT FROM THE CUSTOMER'S SYSMEX SYSTEM WAS 21.3%. ON (B)(6) 2016 THE THB RESULT FROM THE COBAS B 221 SYSTEM WAS 6.3 G/DL. THE RESULT FROM THE CUSTOMER'S SYSMEX SYSTEM WAS 9.1 G/DL. THE HCT RESULT FROM THE COBAS B 221 SYSTEM WAS 14.6%. THE RESULT FROM THE CUSTOMER'S SYSMEX SYSTEM WAS 24.6%. NO ADVERSE EVENT OCCURRED. IT WAS NOTED THAT QUALITY CONTROLS (QC) WERE ACCEPTABLE ON BOTH THE COBAS B 221 SYSTEM AND THE COBAS B 121 SYSTEM. THE LAST TIME PREVENTIVE MAINTENANCE WAS PERFORMED ON THE B 221 SYSTEM WAS IN JUNE, 2016. LITHIUM HEPARIN SYRINGES WERE USED FOR THE COBAS B 221 AND COBAS B 121 SYSTEM RESULTS. EDTA SYRINGES WERE USED FOR THE SYSMEX RESULTS. IT IS NOT CLEAR IF THE LITHIUM HEPARIN SYRINGES USED FOR THE COBAS B 221 AND COBAS B 121 WERE DRAWN AT THE SAME TIME AS THE EDTA SYRINGES USED FOR THE SYSMEX SYSTEM. THIS INFORMATION WAS REQUESTED. THE INVESTIGATION NOTED THAT BOTH THE COBAS B 221 SYSTEM AND THE COBAS B 121 SYSTEM USE DIFFERENT MEASURING TECHNOLOGIES THAN THE SYSMEX SYSTEM WHICH COULD LEAD TO DIFFERENT RESULTS BETWEEN THE SYSTEMS. ANOTHER POTENTIAL ROOT CAUSE FOR THE DIFFERENCE IN RESULTS MAY BE RELATED TO A PRE-ANALYTIC ISSUE SUCH AS SEDIMENTATION OF THE SAMPLE.

N

Patient 1

IT WAS CLARIFIED THAT THE LITHIUM HEPARIN SYRINGES USED FOR THE COBAS B 221 AND COBAS B 121 WERE DRAWN AT THE SAME TIME AS THE EDTA SYRINGES FOR THE SYSMEX.

N

Patient 1

A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. THE INVESTIGATION NOTED THAT THE MCHC (MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION) RESULTS ON (B)(6) 2016, (B)(6) 2016 AND (B)(6) 2016 WERE QUITE HIGH AND PROBABLY NOT RELATED TO THE CONDITION OF THE PATIENT. THE MCHC IS THE QUOTIENT OF THB/HCT AND USES A UNIT OF MEASURE OF G/DL. THE DETECTION METHOD FOR THB IS DIFFERENT. THE HIGH MCHC VALUES ARE PROBABLY CAUSED BY THE SAME ISSUE THAT CAUSED THE DISCREPANT THB RESULTS WHEN COMPARED TO THE SYSMEX RESULTS. THE MOST COMMON CAUSE OF SUCH AN ISSUE IS THE USE OF AN IN-HOMOGENEOUS SAMPLE. SEDIMENTATION OF ERYTHROCYTES CAN OCCUR IN THE CONTAINER IF THE SAMPLE IS NOT MEASURED IMMEDIATELY. IF THE SAMPLE IS NOT MEASURED IMMEDIATELY, THE CONTAINER SHOULD BE ROLLED PRIOR TO MEASUREMENT. BASED ON THE INFORMATION AVAILABLE FOR INVESTIGATION, A PRE-ANALYTIC ISSUE IS THE MOST LIKELY ROOT CAUSE OF THE ERRONEOUS RESULTS.