MAUDE MDR 3196117

MDR report key
3196117
Report number
1823260-2013-03937
Event key
0
Event type
3
Date of event
2013-05-28
Date received
2013-06-28
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 JENNIFER WOLFGRAM
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
1OMNI B221BLOOD GAS ANALYZERROCHE DIAGNOSTICSJJCNA03337154001NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-06-280

Event Narratives#

D

Patient 1

THE CUSTOMER STATED THE ANALYZER PRODUCED AN ARTERIAL BLOOD GAS REPORT ON A PATIENT AND SENT THE RESULTS TO THE LIS. THE INTENSIVE CARE DOCTOR CONTACTED THE LABORATORY BECAUSE THE RESULTS DID NOT MATCH PREVIOUS RESULTS OR FIT THE PATIENT'S CLINICAL PICTURE. IT WAS THEN DISCOVERED THE PATIENT HAD NOT HAD A SAMPLE DRAWN AT THAT TIME. FURTHER INVESTIGATION BY THE CUSTOMER DETERMINED THE ANALYZER PRODUCED ANOTHER BLOOD GAS REPORT ON ANOTHER PATIENT WITH THE IDENTICAL TIME STAMP. THE CUSTOMER STATED THESE RESULTS WERE NOT STORED IN THE ANALYZER, NOR WERE THEY TRANSMITTED TO THE LIS, BUT THAT THEY WERE CORRECT RESULTS FOR THAT PATIENT. THE RESULTS THAT WERE INCORRECTLY REPORTED ON THE FIRST PATIENT WERE: PH = 7.335 PCO2 = 5.64 KPA PO2 = 23.01 KPA SO2 = 99.2% BEECF = -3.8 MMOL/L NA+ = 140.7 MMOL/L K+ = 3.80 MMOL/L CL- = 104.6 MMOL/L CA2+ = 1.216 MMOL/L HCT(C) = 0.415 COHB = 0.011 METHB = 0.007 GLU = 6.2 MMOL/L LAC = 1.4 MMOL/L THERE WERE NO ADVERSE EVENTS.

N

Patient 1

THE EVENT OCCURRED IN (B)(6).

N

Patient 1

SEX HAS BEEN UPDATED. THE SERIAL NUMBER OF THE DEVICE IS (B)(4) THE PATIENT'S CURRENT CONDITION IS STABLE. THE INVESTIGATION DETERMINED IT IS POSSIBLE TO GENERATE TWO PRINTOUTS WITH THE SAME TIMESTAMP BUT DIFFERENT PATIENT IDS. THE NURSE INVOLVED IN THE EVENT WAS INTERVIEWED. HE STATED, THE NAME CHANGE WAS DONE WHILE THE MEASUREMENT WORKFLOW WAS RUNNING. HE STATED, HE USED THE "LAST PATIENTS" FUNCTION AND MOST LIKELY ACCIDENTLY PICKED THE WRONG PATIENT FROM THE LIST.

N

Patient 1

MEDWATCH (MANUFACTURING SITE) WAS UPDATED.