FDA.reportPublic FDA data

MAUDE MDR 7326478

MDR report key
7326478
Report number
1823260-2018-00734
Event key
0
Event type
3
Date of event
2018-01-31
Date received
2018-03-09
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
1ROCHE OMNI SBLOOD GAS ANALYZERROCHE DIAGNOSTICSJJCNA03337154001NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-090

Event Narratives#

N

Patient 1

(B)(4). THIS EVENT OCCURRED IN (B)(6).

D

Patient 1

THE CUSTOMER RECEIVED A QUESTIONABLE TOTAL HEMOGLOBIN (THB) RESULT FOR ONE PATIENT WITH A COBAS B221 ANALYZER WHEN COMPARED TO A XN 1000 HEMATOLOGY INSTRUMENT. OF THE DATA PROVIDED, THERE WERE ERRONEOUS RESULTS FOR THE THB AND HEMATOCRIT (HCT) TESTS. THE THB RESULT FROM THE COBAS B 221 WAS 5.45 G/DL. THE THB RESULT USING THE SAME SAMPLE IN ANOTHER LABORATORY WITH AN XN 1000 INSTRUMENT WAS 9.60 MG/DL. THE HCT RESULT FROM THE B 221 WAS 15.0%. THE HCT RESULT USING THE SAME SAMPLE IN ANOTHER LABORATORY WITH AN XN 1000 INSTRUMENT WAS 29.50%. THE CUSTOMER STATED THEY OBSERVED THIS SAME ISSUE WITH A DIFFERENT SAMPLE ON (B)(6) 2018. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE QC RESULTS WERE CHECKED AND DETERMINED TO BE ACCEPTABLE. THE CUSTOMER STATED THAT THEY USED "FACTORY HEPARINIZED SYRINGES". THE LOT NUMBER AND EXPIRATION DATE OF THE THB CUVETTE WAS REQUESTED BUT WAS NOT PROVIDED.