FDA.reportPublic FDA data

MAUDE MDR 7299088

MDR report key
7299088
Report number
1823260-2018-00572
Event key
0
Event type
3
Date of event
2018-02-01
Date received
2018-02-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
12018-02-270

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6).

D

Patient 1

THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR FIVE PATIENT SAMPLES TESTED FOR POTASSIUM (K+) AND CALCIUM (CA2+) ON A COBAS B 221=ROCHE OMNI S6 SYSTEM (B221). THE ERRONEOUS RESULTS FOR THE SECOND THROUGH FIFTH SAMPLES WERE NOT REPORTED OUTSIDE OF THE LABORATORY TO THE ATTENDING PHYSICIAN. IT WAS ASKED, BUT IT IS NOT KNOWN IF AN ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY FOR THE FIRST SAMPLE. THE CUSTOMER HAS NOT RECEIVED ANY COMPLAINTS ABOUT ADDITIONAL ERRONEOUS RESULTS FROM PHYSICIANS. THE FIRST SAMPLE INITIALLY RESULTED WITH A K+ VALUE OF 6.05 MMOL/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER, RESULTING WITH A K+ VALUE OF 3.52 MMOL/L. THIS SAMPLE INITIALLY RESULTED WITH A CA2+ VALUE OF 1.070 MMOL/L ACCOMPANIED BY A DATA FLAG AND WHEN REPEATED ON THE SAME ANALYZER, IT RESULTED AS 1.180 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED WITH A K+ VALUE OF 11.86 MMOL/L. THE SAMPLE WAS REPEATED ON A SECOND B221 ANALYZER, RESULTING WITH A K+ VALUE OF 3.22 MMOL/L. THE THIRD SAMPLE INITIALLY RESULTED WITH A K+ VALUE OF 5.72 MMOL/L. THE SAMPLE WAS REPEATED ON A SECOND B221 ANALYZER, RESULTING WITH A K+ VALUE OF 3.08 MMOL/L. THE FOURTH SAMPLE INITIALLY RESULTED WITH A K+ VALUE OF 5.27 MMOL/L. THE SAMPLE WAS REPEATED ON A SECOND B221 ANALYZER, RESULTING WITH A K+ VALUE OF 3.26 MMOL/L. THE FIFTH SAMPLE INITIALLY RESULTED WITH A K+ VALUE OF 6.5 MMOL/L. THE SAMPLE WAS REPEATED ON A SECOND B221 ANALYZER, RESULTING WITH A K+ VALUE OF 3.80 MMOL/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THERE HAVE BEEN NO ALARMS GENERATED ON THE ANALYZER. THE ANALYZER IS NEW. QUALITY CONTROLS HAVE BEEN IN RANGE. ALL SAMPLES WERE MIXED ON AN AGITATOR FOR 10 MINUTES PRIOR TO THE FIRST MEASUREMENT. THE SAMPLES WERE THEN PLACED BACK ON THE AGITATOR AND THEN REPEATED 15 MINUTES LATER. THE K+ AND CA2+ ELECTRODE/CARTRIDGE LOT NUMBERS AND EXPIRATION DATES WERE ASKED FOR, BUT NOT PROVIDED.