MAUDE MDR 2064110

MDR report key
2064110
Report number
3005529799-2011-00005
Event key
0
Event type
3
Date of event
2011-03-21
Date received
2011-03-24
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
SUSAN KOSS
Address
3600 GANTZ ROAD GROVE CITY OH 43123 US
Phone
614-614-6143
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AIA-360AUTOMATED IMMUNOASSAY ANALYZERTOSOH HI-TEC, INC.,OMIAIA-360019945R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-03-2401. O

Event Narratives#

D

Patient 1

IMPRECISION, ACCOUNT CALLED, HAD RUN TWO DIFFERENT PTS AND RESULTS 3.0 FOR TROPONIN. ACCOUNT REPEATED WITH NEW SAMPLES ONE HR LATER AND BOTH PTS WERE LESS THAN LOW. ACCOUNT REPEATED FIRST TWO SAMPLES AND RESULTS LESS THAN LOW. OTHER INSTRUMENT PERFORMING AS EXPECTED. NO ERROR CODES ON PRINTOUT. FIELD SERVICE ENGINEER NOTIFIED. ON (B)(6) 2011, PTS TRANSFERRED TO CCU DUE TO HIGH CTN ON INITIAL SAMPLE THAT WAS RUN. CALLED TO FIND OUT IF PTS WERE ACTUALLY TREATED. TECH TO DISCUSS WITH PHYSICIAN. ON (B)(4) 2011 F/U: PT TREATMENT. NO RESPONSE. ON (B)(4) 2011 F/U: INFO GIVEN TO PATHOLOGIST WHO HAD NOT YET RESPONDED. UNCLEAR TO HIM AS TO WHETHER TREATMENT WAS AFFECTED. ONE RECEIVED HEPARIN DRIP RELATED TO HIGH CTN. OTHER THAN THAT NO INTERVENTIONS WERE DONE. HE WAS TOLD A BEAD WAS STUCK ON THE WASH PROBE TIP. NOTIFIED TECHNICAL SUPPORT MGR.

N

Patient 1

SERVICE REPORT INFO. ON (B)(6) 2011 - CUSTOMER HAD RUN A CALIBRATION WITH TEST CUP LOT# A919372 AND CONTROLS WHICH RECOVERED WITHIN RANGE IN THE AM BEFORE FIELD SERVICE ENGINEER ARRIVED AND RUNNING PTS ON ANALYZER. CALIBRATOR LOT# AZ39338, CONTROLS BIO-RAD LIQUICHEK LOT# 23500, SUBSTRATE LOT# 1Y60030 EXP DATE 03/26/2011, WASH LOT# 1X70011 EXP DATE 04/21/2011, DILUENT LOT# 1780034 EXP DATE 04/15/2011, TEST CUP LOT# A919370 EXP DATE: 09/2011. FOUND BEAD LODGED IN TIP OF B/F WASH PROBE. CLEANED. CHECKED SUBSTRATE TEMP, HIGH AT 41.5 DEGREES ADJUSTED TO 39.5 DEGREES. CHECKED WASH HEATER TEMP AT 40.5 DEGREES ADJUSTED TO 39.7 DEGREES. TABLE TEMP AT 37.3 DEGREES. FOUND SPOT ON DETECTOR LENS, CLEANED. CHECKED ERROR CODES, ONLY LISTING FOR (B)(6) WAS 2014 AND 3018 ERRORS. THE 3018 ERROR IS FOR A FULL WASTE CONTAINER, 2014 FOR NOT ENOUGH SAMPLE. PERFORMED SAMPLE LEVEL DETECTION CALIBRATION FOR THE 2014 ERROR CODE. TUBE VALUES WITHIN SPECIMEN CUP VALUES, LOW 140'S SHOULD BE 180-200 ADJUSTED FROM 140 TO 183. VERIFIED OPERATION OF ALL SYRINGES, PUMPS AND B/F WASH PROBE. RAN TOSOH CALIBRATORS LOT AZ39388. RAN BIO-RAD LIQUICHEK LOTS 23501 AND 23503 CONTROL #1 AND #3. THE #1 RANGE 0.27-0.93, RECOVERED AT 0.46, #3 RANGE 28.2-46.9 RECOVERED AT 37.78. RAN N=10 PRECISION RUN ON #1 AND #3 CONTROL. THE #1 MEAN = 0.379, SD= 0.011, %CV= 2.95, #3 MEAN= 32.07, SD= 0.67, %CV= 2.09. NO FURTHER ACTION REQUIRED BY TBI FIELD SERVICE.