FDA.reportPublic FDA data

MAUDE MDR 5883514

MDR report key
5883514
Report number
1823260-2016-01224
Event key
0
Event type
3
Date of event
2016-08-08
Date received
2016-08-17
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 *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-08-170

Event Narratives#

N

Patient 1

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

D

Patient 1

THE CUSTOMER RECEIVED A QUESTIONABLE TOTAL HEMOGLOBIN (THB) RESULT FOR ONE PATIENT WHEN COMPARED TO ANOTHER COBAS B221 ANALYZER AND THE RESULT FROM A COBAS 8000 ANALYZER IN THE LABORATORY. THE RESULT FROM COBAS B221 SERIAL NUMBER (B)(4) WAS 5.1 G/DL. THE RESULT FROM COBAS B221 SERIAL NUMBER (B)(4) WAS 9.4 G/DL. THE RESULT FROM THE LABORATORY ANALYZER WAS 7.8 G/DL AND WAS BELIEVED TO BE CORRECT. INFORMATION CONCERNING IF THE ERRONEOUS RESULT WAS REPORTED TO A PERSON TREATING THE PATIENT WAS REQUESTED, BUT IT WAS UNKNOWN. IT WAS NOTED A NURSE PERFORMED THE THB TESTING ON THE ANALYZER. THE PATIENT WAS NOT HARMED AS ONLY THE RESULTS FROM THE LABORATORY WERE USED FOR PATIENT TREATMENT. THE LOT NUMBER AND EXPIRATION DATE OF THE THB CUVETTE WAS REQUESTED, BUT WAS NOT PROVIDED. ON (B)(6) 2016, THE FIELD SERVICE REPRESENTATIVE PERFORMED TESTING WITH A FRESH BLOOD SAMPLE FROM THE SAME PATIENT AND THE RESULTS WERE: COBAS B221 SERIAL NUMBER (B)(4): 8.0 G/DL AND 8.1 G/DL. COBAS B221 SERIAL NUMBER (B)(4): 8.1 G/DL AND 8.1 G/DL. THE RESULT FROM THE COBAS 8000 ANALYZER WAS 7.8 G/DL.

N

Patient 1

BASED ON THE PROVIDED DATA, THE ISSUE WAS MOST LIKELY CAUSED BY AIR BUBBLES IN THE SAMPLE OR CUVETTE OF THE COOX MODULE DURING TESTING. IT IS NOT POSSIBLE TO CLEARLY IDENTIFY THE ORIGIN OF THESE BUBBLES. THERE WAS A POSSIBILITY THAT THE BUBBLES COULD HAVE BEEN GENERATED BY THE SYSTEM, BUT NO SYSTEMATIC OCCURRENCE OF BUBBLES WAS OBSERVED WITHIN THE DATA. THE AIR BUBBLES MIGHT HAVE ALSO BEEN CAUSED IN THE PRE-ANALYTIC PROCESSING OF THE SAMPLE. THE INVESTIGATION OF ALL OF THE PROVIDED INSTRUMENT DATA SHOWED NO SYSTEM RELATED PROBLEM.