AIA-900

Report

Report Number: 8031673-2018-04141
Event Type: Malfunction
Date Received: March 28, 2018
Date of Event: May 6, 2016
Report Date: March 28, 2018
Manufacturer: TOSOH CORPORATION
Product Code: KHO
PMA / PMN Number: K971103
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

H10.ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA 2017-0007. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H3.DEVICE BY MANUFACTURER: ON 6-MAY-2016, A TECHNICAL SUPPORT SPECIALIST (TSS) ADDRESSED THE REPORTED EVENT WHERE THE CUSTOMER INFORMED THAT THEY HADB12 AND FOLATE FAILURES. ON 9-MAY-2016, DURING A FOLLOW-UP CALL, THE CUSTOMER INFORMED THEY CALIBRATED B12 LOT 003. 40320 QC WERE - 479, 878, 932. ALL WERE VERY CLOSE TO THE MEAN. CUSTOMER RAN A PRECISION STUDY OF B12'S - CV 5.5%, MEAN 402.15 AND WILL TRY TO REPEAT AAB SAMPLES BUT WAS STORING THE SAMPLES IN THE REFRIGERATOR FOR 3 WEEKS. 24-MAY-2016 CALLED CUSTOMER BACK FOR AN UPDATE. 26-MAY-2016 CALLED CUSTOMER, WHO REPORTS THAT AAB 2Q B12 FAILED AGAIN, MAKING THIS THE 3RD EVENT IN A ROW. CUSTOMER FAXED DOCUMENT FOR AAB FROM THE 3Q AND ALSO THE OFF CYCLE REPORTING, FROM 3-MAY-2016. TSS CALLED AAB WHO REPORTS THAT B12 HAD 11 LABS REPORTING - 9 LABS HAD SCORE OF 100%, 1 LAB HAD 1 ANSWER INCORRECT AND 1 LAB HAD BOTH SAMPLES REPORTED INCORRECTLY. THIS LAB HAS NOT PASSED A PT EVENT FOR B12 SINCE REPORTING 3Q 2015. THE CUSTOMER STATED THAT FOR FOLATES, THE 3Q 2015 WAS 100% CORRECT, 1Q 2016 SCORE WAS 50% AND THE 2Q 2016, BOTH SAMPLES WERE REPORTED INCORRECTLY, SCORE 0%. TSS THEN CALLED FSE WHO HAS BEEN ONSITE. HE SAID THAT HE NOTICED THAT THE WASH PROBE MAINTENANCE CLEANING WAS DEFICIENT - WHEN HE ARRIVED THE BF PROBES, 1 AND 2 TIPS WERE BLACK AND THAT THE PROBES SHOULD BE CLEANED WEEKLY AND TIPS CHANGED MONTHLY. HE SAID THAT THIS IS CRITICAL ESPECIALLY WITH B12 AND FOLATE SINCE THE WASH PROBE GOES INTO THE STC CUP AND TEST CUP MORE THAN ONCE. TS WILL FOLLOW UP WITH CUSTOMER NEXT WEEK. 3-JUN-2016 TSS RECEIVED THE REQUESTED QC DATA AND MAINTENANCE LOG. ALL OF THE LAST 7 MONTHS OF LOG SHEETS DID HAVE WEEKLY AND MONTHLY BF PROBE MAINTENANCE CHECK AS BEING COMPLETED. [FSE DID REPORT THAT THE BF PROBES WERE DIRTY AND LOOKED LIKE THE TIPS HAD NOT BEEN CHANGED. B12'S ARE ONLY RUN TWICE A MONTH] 16-JUN-2016 AFTER CAREFUL REVIEW OF ALL REQUESTED DATA: 1. REVIEWED B12 AND FOLATE TEST FILES ON 900 AND THE PARAMETERS ARE CORRECT FOR BOTH B12 AND FOLATE TEST FILES. 2. REVIEWED CALIBRATION FROM 3/21 B12 LOT 003 - RATES SEEM HIGN AND QC IS ALSO HIGH REVIEWED CAL ON 3/22 LOT 002 - RATES SEEM HIGH , UNSURE ABOUT QC DATA - RAN PRIOR TO FSE SC. REVIEWED CAL ON 3/24, LOT 002, FSE RAN AND BR AND MAC QC ARE IN RANGE. BR 40320 QC IN RANGE - 396, 538 , 644. 3. REVIEWED AVAILABLE QC SENT FOR B12, B12 IS ONLY RUN TWICE PER MONTH: BR 40320 L1 QC FROM 12'15 ARE IN RANGE - 454.0. 453.0, 451.0 [ 319-592] BR 40323 L3 QC FROM 10/19/15 TO 10/30/15 - 895.7, 898.0, 900.0, 945.4 [628-1165] BR QC ON 5/23 - 396, 396 AND 538, 644. L1 & L2 OK AND L3 IS LOW [628-1165] 4. REVIEWED AAB DATA - CALLED AAB , THIS LAB FAILED THE LAST 3 PROFICIENCY TESTING: A. FOR THE 3Q 2015, #1 SPECIMEN WAS HIGH 1034 [294-547]. #2 SPECIMEN 689 [384-714] . THIS SPECIMEN WOULD HAVE BEEN CORRECT BUT THERE WAS NO CODE SUBMITTED FOR THE REAGENT, BOTH SAMPLES WERE GRADED AS INCORRECT. B. FOR THE 1Q 2016, SPEC #1 - 485[60-180] SPEC#2 675 [945-1745] AUREA SAID THAT WHEN SHE REPEATED THE SPECIMENS, THE RESULTS WERE IN RANGE AND ACCEPTABLE. C. FOR THE 2Q 2016 - SPEC #1 517 [813-1510] SPEC #2 512 [615-1141 SPECIMENS REPEATED ON 5/09 AND #1- 1112 AND #2 - 1110 AND IN ACCEPTABLE RANGE. 5. CONCLUSIONS - COMMENT MADE BY CSS THAT CUSTOMERS PIPETTING TECHNIQUE IS DEFICIENT - FSE WAS DISPATCHED TO CHECK 900 OUT AND REPORTS THAT BOTH WASH TIPS WERE VERY DIRTY - HE CLEANED AND DISCUSSED WITH CUSTOMER HOW TO MAINTAIN. HE CALIBRATED B12 , BR AND MAC WERE IN RANGE. - CUSTOMER STATES PT REAGENT IS ALWAYS FRESH WITH EACH RUN - SHE RUNS TWICE A MONTH, SUBSTRATE LASTS FOR 10 DAYS. - WAS TOLD BY AAB THAT THIS LAB IS THE ONLY LAB WHO HAS FAILED , 11 LABS REPORTING - 9 LABS WERE 100 %, 1 LAB WAS AT 50% AND THIS LAB WAS AT 0%. - CUSTOMER HAS NEVER FAILED ANY OF THE OTHER ANALYTES, ONLY B12 AND FOLATE. - THE QC DATA WHICH WAS SUBMITTED WAS INCOMPLETE, NO RESULTS POSTED FOR INDIVIDUAL QC DATA POINTS - THIS LAB IS UNABLE TO REPORT B12 FOR 6 MONTHS BECAUSE OF THE 3 AAB FAILURES IN A ROW. ASKED CUSTOMER IF DURING THIS TIME, SHE SHOULD CALIBRATE B12 AND RUN QC . SHE WILL CLOSELY MONITOR AND REPORT BACK IF RESULTS ARE OUT OF RANGE. NO FURTHER ACTION REQUIRED. THE PROBABLE CAUSE OF THE EVENT WAS FAILED AAB PROFICIENCY TESTING.

Description of Event or Problem · 0

ON (B)(6) 2016, A CUSTOMER REPORTED FAILED B12 AND FOLATE PROFICIENCY TESTING (PT) WITH THEIR AIA-900 ANALYZER. CUSTOMER REPORT REPORTS FAILURE OF AAB (LAB) SPECIAL SURVEY ON BOTH SPEC #1 - 909 [945-1755] AND SPEC #2 - 546 [60-180}. THESE SPECIMENS WERE RUN ON 4/20. BR QUALITY CONTROL (QC) 40320 L1 391 [319-592]; L2 589 [475-882]; L3 757 [628-1165] B12 CAL'D ON 3/24 CUP LOT 002. THE CUSTOMER STATED THEY RUN A NEW B12 PT WITH EVERY RUN. SUBSTRATE IS USUALLY EVERY 2 WEEKS. CALIBRATION QC RESULTS WERE FAXED FOR REVIEW. CUSTOMER DOES NOT HAVE ANYMORE OF LOT 002 BUT CALIBRATED WITH B12 LOT 003 AND WILL RUN A PRECISION STUDY. A TECHNICAL SUPPORT SPECIALIST (TSS) ADDRESSED THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING B12 PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
219804	AIA-900	AIA-900	KHO	TOSOH CORPORATION	AIA-900

Patients

Seq	Age	Sex	Outcome	Treatment
1