PROCLEIX ULTRIO ELITE ASSAY

Report

Report Number: 2032600-2024-00011
Event Type: Injury
Date Received: July 16, 2024
Date of Event: May 29, 2024
Report Date: August 15, 2024
Manufacturer: GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Product Code: QHO
UDI-DI: 00859882007672
PMA / PMN Number: BL125652
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Description of Event or Problem · 0

SAMPLE ID (B)(6). GRIFOLS CUSTOMER HAEMA AG (GERMANY) REPORTED ONE PLASMA SAMPLES THAT WAS NONREACTIVE IN A POOL OF 96 WHEN TESTED IN UE ML 707145 BUT WAS CONFIRMED HBSAG AND ANTI-HBC POSITIVE IN INDIVIDUAL DONOR TESTING (IDT). IT WAS NOT TESTED IDT IN UE. THE PLASMA SAMPLE WAS INITIALLY REACTIVE WHEN TESTED IN IDT IN DHBV, AND INTERMITTENTLY REACTIVE WHEN BOTH SERUM AND PLASMA WERE RETESTED IDT IN DHBV AS PART OF AN INTERNAL VALIDATION FOR SERUM AND PLASMA EQUIVALENCY. NO SAMPLE REMAINS FOR INVESTIGATION. RECORD STATES NO PATIENT AT RISK DUE TO REACTIVE HBV SEROLOGY. RELEASE TESTING: ON (B)(6) 2024: HBSAG REACTIVE (SERUM). ON (B)(6) 2024: ANTI-HBC REACTIVE (SERUM) ON (B)(6) 2024: P96 UE NONREACTIVE (EDTA). ON (B)(6) 2024: IDT DHBV REACTIVE (S/CO 23.01) (EDTA NAT). INTERNAL VALIDATION TESTING: ON (B)(6) 2024: IDT DHBV NONREACTIVE (S/CO 0.00) (EDTA IH), ON (B)(6) 2024: IDT DHBV REACTIVE (S/CO 23.02) (SERUM), ON (B)(6) 2024: IDT DHBV NONREACTIVE (S/CO 0.00) (EDTA NAT), ON (B)(6) 2024: IDT DHBV NONREACTIVE (S/CO 0.00) (EDTA IH), ON (B)(6) 2024: IDT DHBV REACTIVE (S/CO 2.14) (SERUM), ON (B)(6) 2024: IDT DHBV NONREACTIVE (S/CO 0.00) (EDTA NAT), ON (B)(6) 2024: IDT DHBV NONREACTIVE (S/CO 0.00) (EDTA IH), ON (B)(6) 2024: IDT DHBV NONREACTIVE (S/CO 0.00) (SERUM). NOTE: SERUM WAS FROZEN AND NOT CENTRIFUGED BEFORE TESTING. SOME SAMPLES DILUTED WITH DEIONIZED WATER. INVESTIGATION SUMMARY: DHR REVIEW DID NOT IDENTIFY ANY ISSUE WITH HBV SENSITIVITY. POOLS ARE ALLOWED PER THE UE IFU, BUT POOL SIZE IS NOT SPECIFIED. THE HBV 95% LOD FOR UE 4.3 IU/ML. FOR A SINGLE HBV SAMPLE IN A POOL OF 96 TO BE DETECTED, IT WOULD HAVE TO HAVE AN HBV CONCENTRATION >400 IU/ML. THOUGH QUANTITATION ON THE SAMPLE IN QUESTION WAS NOT AVAILABLE, IT IS LIKELY THE POOL WAS BELOW THE LOD OF THE ASSAY. THE SAMPLE WAS REPEAT REACTIVE WHEN TESTED IDT, AND NONREACTIVE WHEN DILUTED WITH WATER. DILUTION WITH WATER IS NOT RECOMMENDED. THE MOST LIKELY ROOT CAUSE OF THE INITIAL UE NONREACTIVE POOL IS LOW TITER AS A RESULT OF POOL DILUTION. THE INDIVIDUAL DONOR DHBV RESULT WAS CONSISTENT WITH SEROLOGY. FOLLOW-UP INFORMATION FOR THIS REPORT WILL BE PROVIDED WHEN AVAILABLE.

Description of Event or Problem · 0

SAMPLE ID (B)(6). GRIFOLS CUSTOMER HAEMA AG (GERMANY) REPORTED ONE PLASMA SAMPLES THAT WAS NONREACTIVE IN A POOL OF (B)(4) WHEN TESTED IN UE ML (B)(4) BUT WAS CONFIRMED HBSAG AND ANTI-HBC POSITIVE IN INDIVIDUAL DONOR TESTING (IDT). IT WAS NOT TESTED IDT IN UE. THE PLASMA SAMPLE WAS INITIALLY REACTIVE WHEN TESTED IN IDT IN DHBV, AND INTERMITTENTLY REACTIVE WHEN BOTH SERUM AND PLASMA WERE RETESTED IDT IN DHBV AS PART OF AN INTERNAL VALIDATION FOR SERUM AND PLASMA EQUIVALENCY. NO SAMPLE REMAINS FOR INVESTIGATION. RECORD STATES NO PATIENT AT RISK DUE TO REACTIVE HBV SEROLOGY. RELEASE TESTING: (B)(6)2024: HBSAG REACTIVE (SERUM). (B)(6)2024: ANTI-HBC REACTIVE (SERUM). (B)(6)2024: P96 UE NONREACTIVE (EDTA). (B)(6)2024: IDT DHBV REACTIVE (S/CO 23.01) (EDTA NAT). *INTERNAL VALIDATION TESTING: (B)(6)2024: IDT DHBV NONREACTIVE (S/CO 0.00) (EDTA IH). 3(B)(6)2024: IDT DHBV REACTIVE (S/CO 23.02) (SERUM). (B)(6)2024: IDT DHBV NONREACTIVE (S/CO 0.00) (EDTA NAT). (B)(6)2024: IDT DHBV NONREACTIVE (S/CO 0.00) (EDTA IH). (B)(6)2024: IDT DHBV REACTIVE (S/CO 2.14) (SERUM). (B)(6)2024: IDT DHBV NONREACTIVE (S/CO 0.00) (EDTA NAT). (B)(6)2024: IDT DHBV NONREACTIVE (S/CO 0.00) (EDTA IH). (B)(6)2024: IDT DHBV NONREACTIVE (S/CO 0.00) (SERUM). NOTE: SERUM WAS FROZEN AND NOT CENTRIFUGED BEFORE TESTING. *SOME SAMPLES DILUTED WITH DEIONIZED WATER. INVESTIGATION SUMMARY: DHR REVIEW DID NOT IDENTIFY ANY ISSUE WITH HBV SENSITIVITY. POOLS ARE ALLOWED PER THE UE IFU, BUT POOL SIZE IS NOT SPECIFIED. THE HBV 95% LOD FOR UE 4.3 IU/ML. FOR A SINGLE HBV SAMPLE IN A POOL OF (B)(4) TO BE DETECTED, IT WOULD HAVE TO HAVE AN HBV CONCENTRATION >400 IU/ML. THOUGH QUANTITATION ON THE SAMPLE IN QUESTION WAS NOT AVAILABLE, IT IS LIKELY THE POOL WAS BELOW THE LOD OF THE ASSAY. THE SAMPLE WAS REPEAT REACTIVE WHEN TESTED IDT, AND NONREACTIVE WHEN DILUTED WITH WATER. DILUTION WITH WATER IS NOT RECOMMENDED. THE MOST LIKELY ROOT CAUSE OF THE INITIAL UE NONREACTIVE POOL IS LOW TITER AS A RESULT OF POOL DILUTION. THE INDIVIDUAL DONOR DHBV RESULT WAS CONSISTENT WITH SEROLOGY. FOLLOW-UP INFORMATION FOR THIS REPORT WILL BE PROVIDED WHEN AVAILABLE. 15AUG2024 UPDATE: RISK ASSESSMENT: SEVERITY: CRITICAL A SINGLE BLOOD SCREENING FALSE NEGATIVE (FN) RESULT CAN CAUSE MULTIPLE INFECTIONS. THE SEVERITY OF A BLOOD SCREENING FALSE NEGATIVE IS CRITICAL. PROBABILITY: REMOTE. THE PROBABILITY OF A FALSE NEGATIVE RESULT IN ML (B)(4) IS REMOTE BASED ON THE PREVIOUS EVENTS SEARCH. FALSE NEGATIVE RESULTS DO OCCUR BUT ARE RARE. OVERALL RISK: ACCEPTABLE. PANTHER ASSAY SPECIFIC RISK ANALYSIS FOR BLOODBANK ASSAYS, GDSS-RD-RSK-000043 REV. 2.0 AND PRODUCT SAFETY RISK MANAGEMENT PROCEDURE, GDSS-MS-SOP-000004 VERSION 13.0 WERE REVIEWED TO ASSESS RISK. NEW RISK TO PATIENT SAFETY WAS NOT IDENTIFIED. THERE WERE NO RELATED NONCONFORMANCES NOTED IN THE MANUFACTURING RECORD OR AS PART OF A SEARCH OF THE NONCONFORMANCE RECORDS FOR THIS LOT NUMBER. PRODUCT IMPACT NO IMPACT TO PRODUCT WAS IDENTIFIED. REVIEW OF THE QC RELEASE DATA AND A PREVIOUS EVENTS SEARCH IN THE GRIFOLS COMPLAINT SYSTEM INDICATE THAT THE ASSAY IS WORKING AS DESIGNED. CUSTOMER IMPACT THE SAMPLES WERE BLOCKED FROM USE DUE TO THE REACTIVE SEROLOGY RESULTS. THE IMPACT TO THE CUSTOMER WAS QUESTIONING THE DISCORDANT DHBV RESULTS FOR THE PURPOSE OF THE INTERNAL VALIDATION. FOLLOWING ISO 14971, GRIFOLS RISK ASSESSMENT IS BASED ON SEVERITY OF A HARM OR IMPACT TO HUMAN HEALTH AND THE PROBABILITY OF OCCURRENCE OF HARM OR IMPACT TO HUMAN HEALTH. BASED ON THE SEVERITY RATING OF ·CRITICAL· AND PROBABILITY RATING OF ·REMOTE·, THE OVERALL RISK POSED BY A FALSE NEGATIVE ULTRIO ELITE RESULT IS DETERMINED TO BE ACCEPTABLE. INVESTIGATION: 1. CUSTOMER DATA REVIEW THE INSTRUMENT DATA WAS REVIEWED AND NOTHING UNUSUAL WAS NOTED IN THE UE SCREENING OR DISCRIMINATORY RUNS. THERE WERE NO INSTRUMENT ISSUES OBSERVED THAT COULD HAVE CONTRIBUTED TO FALSE NEGATIVE RESULTS. THE CUSTOMER DID REPEAT TESTING IN DHBV WITH THE REMAINING VOLUME OF SERUM AND PLASMA TO DEMONSTRATE EQUIVALENCE BETWEEN THE MATRICES. HOWEVER, THE SERUM AND PLASMA WERE HANDLED DIFFERENTLY AND NOT IN ACCORDANCE WITH THE ULTRIO ELITE INSTRUCTIONS FOR USE (IFU). DIFFERENCES IN HANDLING ARE LISTED BELOW: -SOME SAMPLES WERE DILUTED WITH WATER. DILUTION WITH WATER IS NOT RECOMMENDED. -SERUM WAS FROZEN BEFORE TESTING AND NOT CENTRIFUGED ACCORDING TO IFU, BUT PLASMA WAS NOT FROZEN BEFORE TESTING. -PLASMA WAS TESTED WITHOUT FREEZING, BUT SERUM WAS FROZEN BEFORE TESTING. -SAMPLE STORED OUTSIDE STORAGE RECOMMENDATIONS FOR 2-8°C (SAMPLE WAS STORED >13 DAYS AT 2-8°C). THESE DIFFERENCES AND/OR LOW SAMPLE TITER MAY ACCOUNT FOR THE INTERMITTENT DHBV REACTIVITY SEEN DURING INTERNAL VALIDATION TESTING. TO ELIMINATE THE IMPACT OF SAMPLE HANDLING DURING AN EQUIVALENCE STUDY, THE SERUM AND PLASMA SHOULD BE HANDLED USING THE SAME METHODS AND IN ACCORDANCE WITH THE ASSAY IFU. 2.DEVICE HISTORY RECORD REVIEW THE DHR REVIEW IDENTIFIED NO ISSUES WITH HBV SENSITIVITY IN ML (B)(4). PACKAGE INSERT UPDATE: AN UPDATE TO THE UE PACKAGE INSERT IS IN PROGRESS. A WARNING WILL BE ADDED, STATING THAT ·WHEN USING POOLED SAMPLES, ANALYTICAL SENSITIVITY WILL BE PROPORTIONALLY LOWER BASED ON THE DILUTION FACTOR. · THIS IS THE FINAL REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2517962	PROCLEIX ULTRIO ELITE ASSAY	HIV-1/HIV-2/HCV/HBV DEVICE	QHO	GRIFOLS DIAGNOSTIC SOLUTIONS INC.		707145	00859882007672

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other