ALINITY S HBSAG REAGENT KIT
Report
- Report Number
- 3008344661-2024-00107
- Event Type
- Injury
- Date Received
- September 3, 2024
- Date of Event
- June 26, 2024
- Report Date
- December 13, 2024
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- QHM
- UDI-DI
- 00380740136819
- PMA / PMN Number
- BL 125674
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETE INFORMATION FOR SECTION A1 PATIENT IDENTIFIER = SID (B)(6).
THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED, A SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, LABELING REVIEW, RETURN TESTING, AND FIELD DATA REVIEW. DATA AND INFORMATION PROVIDED WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS WITH LIST NUMBER 06P02-60 AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. A TECHNICAL REVIEW OF CUSTOMER RELEASE TEST DATA AND STATISTICAL PROCESS CONTROL CHARTS FOR ALINITY S 6P02-60 REAGENT LOTS WAS PERFORMED. NO ISSUES WERE IDENTIFIED DURING REVIEW OF CUSTOMER RELEASE TESTING AND THERE WERE NO ISSUES IDENTIFIED REGARDING THE PERFORMANCE OF ALINITY S HBSAG LOT 54640FN00. TO ASSESS THE LEVEL OF HEMOLYSIS, A VISUAL INSPECTION OF THE PRE-MORTEM SAMPLE (B)(6) WAS PERFORMED. THE ASSESSMENT WAS PERFORMED BY APPLYING THE VISUAL INSPECTION REFERENCE GUIDE OF THE AMERICAN RED CROSS BIOMEDICAL SERVICES. PER AMERICAN AND EUROPEAN RED CROSS STANDARDS, THE ACCEPTABLE LEVEL OF HEMOLYSIS (BASED ON VISUAL/QUALITATIVE INSPECTION) IS LESS THAN (B)(4). RESULT FOR SAMPLE (B)(6) = 0.30 %. ADDITIONALLY, TO ASSESS THE LEVEL OF CELLULAR DEBRIS, THE RETURNED SPECIMEN WAS ANALYZED WITH THE AID OF A MICROSCOPE AND HEMACYTOMETER. VARYING LEVELS OF PARTICULATE MATTER WERE OBSERVED. PER THE ALINITY S HBSAG PACKAGE INSERT: FOR ACCURATE RESULTS, SERUM AND PLASMA SPECIMENS SHOULD BE FREE OF FIBRIN, RED BLOOD CELLS, AND OTHER PARTICULATE MATTER. FURTHER, CELL-DYN SAPPHIRE HEMOGLOBIN TESTING ON THE RETURNED SPECIMEN WAS PERFORMED. THE FOLLOWING TABLE SUMMARIZES THE CELL-DYN SAPPHIRE HEMOGLOBIN TESTING ON THE RETURNED SPECIMEN. THE SPECIMENS ARE WITHIN THE ACCEPTABLE LEVEL OF HEMOGLOBIN PER THE ALINITY S HBSAG PACKAGE INSERT (HEMOGLOBIN LEVEL LESS THAN OR EQUAL TO 500 MG/DL). (B)(6) = 127 MG/DL. CLINICAL SPECIFICITY TESTING WAS PERFORMED ON THE RETURNED SAMPLE USING ALINITY S HBSAG REAGENT LOT 57383FN00. LOT 54640FN00 WAS NOT TESTED AS IT HAD ALREADY EXPIRED (2024-07-23) AT THE TIME IT WAS ADDED TO THE COMPLAINT DOCUMENTATION (2024-08-27). THE FOLLOWING TABLE SUMMARIZES THE ALINITY S HBSAG TESTING ON THE RETURNED SPECIMEN: SAMPLE ID / SAMPLE TYPE / S/CO VALUES / HBSAG INTERPRETATION E00000487 / PRE-MORTEM ORGAN / 0.51 / NONREACTIVE A REVIEW OF FIELD DATA FOR ALINITY S HBSAG WAS PERFORMED. OVERALL REACTIVE RATES OF LN 6P02-60 LOT 54640FN00 ACROSS THE CHRIST HOSPITAL (USA), PEER SITES AND ACROSS A WHOLE BLOOD AND PLASMA SCREENING MONITORING GROUP WERE COLLECTED AND ASSESSED. ACROSS THE WHOLE BLOOD AND PLASMA MONITORING GROUP THE PERFORMANCE OF LN 6P02-60 LOT 54640FN00 IS WITHIN PRODUCT REQUIREMENTS AND COMPARABLE TO OTHER LN 6P02-60 LOTS ANALYZED IN THE COMPARISON. LOT 54640FN00: IRR: 0.029 %, RRR: 0.018 %, SPECIFICITY: 99.982%. THE SPECIFICITY PERFORMANCE OF LN 6P02-60 LOT 54640FN00 AT THE CHRIST HOSPITAL (USA) PEER SITES IS WITHIN PACKAGE INSERT REPRESENTATIVE DATA CONFIDENCE INTERVAL OF 93.51 -100.00 FOR CADAVERIC SPECIMENS. THE SPECIFICITY AT THE CHRIST HOSPITAL (USA) WAS OUTSIDE OF THIS CONFIDENCE INTERVAL, 231 AND 81 SAMPLES HAD BEEN TESTED AT THE TIME OF THE REVIEW. (B)(6) HOSPITAL (USA) LOT 54640FN00: IRR: 8.658 %, RRR: 7.792 %, SPECIFICITY: 92.208 %. PEER SITES: LOT 54640FN00: IRR: 2.075 %, RRR: 1.721 %, SPECIFICITY: 98.279 %. BASED ON THE RESULTS OF THIS INVESTIGATION, ALINITY S HBSAG REAGENT LN 6P02-60 LOT 54640FN00 IS PERFORMING AS EXPECTED. HISTORICAL STUDIES HAVE IDENTIFIED DONOR DEMOGRAPHICS (OLDER AGE) AND COMORBIDITIES, AS WELL AS SAMPLE INTEGRITY AS CONTRIBUTING FACTORS FOR FALSE REACTIVE RESULTS ASSOCIATED WITH PRE- AND POST-MORTEM SPECIMEN TESTING ON THE ALINITY S SYSTEM. CUSTOMER EDUCATION TO HIGHLIGHT THE IMPORTANCE OF PRE-ANALYTICS TO OPTIMIZE SAMPLE INTEGRITY WERE CARRIED OUT. A MALFUNCTION WAS IDENTIFIED. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD, THE DEVICES FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE. THIS WAS DETERMINED A MALFUNCTION AS THE SPECIFICITY AT THE CHRIST HOSPITAL (USA) WAS OUTSIDE PACKAGE INSERT REPRESENTATIVE DATA CONFIDENCE INTERVAL. HOWEVER, PEER AND WHOLE BLOOD AND PLASMA USE OF THESE LOTS WAS SUFFICIENT TO DETERMINE THE LOT IS NOT ASSOCIATED WITH A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY.
UPDATE: SECTION H6 ADDITIONAL TYPES OF INVESTIGATION ADDED B11, B12, AND B14
THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HBSAG RESULTS WERE GENERATED FOR A POTENTIAL PRE-MORTEM DONOR OF ADVANCED AGE. THE CUSTOMER STATED THAT LIVER TRANSPLANTATION WAS A POSSIBILITY AND NO SPECIFIC RECIPIENT HAD BEEN IDENTIFIED, HOWEVER FURTHER EVALUATION AND CONSIDERATION FOR A POTENTIAL RECIPIENT WAS NO LONGER PURSUED AFTER RECEIPT OF THE REACTIVE RESULTS, AS THERE WERE NO SUITABLE RECIPIENTS TO RECEIVE THE LIVER FROM A DONOR OF ADVANCED AGE WITH SUSPICION/CONCERN OF HBSAG AND THEREFORE ORGAN RECOVERY WAS ABORTED. THE CUSTOMER FURTHER STATED THAT THEY WOULD HAVE CONTINUED WITH EVALUATION AND POTENTIAL FOR THIS CASE IF THE RESULTS HAD BEEN NONREACTIVE. NO NEUTRALIZING CONFIRMATORY TESTING PERFORMED FOR THE REACTIVE ALINITY S HBSAG RESULTS. NAT TESTING, BIORAD EIA, AND FURTHER REPEAT TESTING ON THE ALINITY S WERE NONREACTIVE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE = 1.0 S/CO IS REACTIVE): (B)(6) 2024 SID (B)(6): ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 1.38, 1.31, 1.39. SID (B)(6): PANTHER RESULT = NONREACTIVE. (B)(6) 2024 SID (B)(6): ALINITY S HBSAG RESULT (PROCESSED ON (B)(6)) = 1.74, REPEAT RESULT = 0.59 NONREACTIVE (PROCESSED ON (B)(6)). (B)(6) 2024 SID (B)(6): EDTA TUBE USED FOR INITIAL PANTHER TESTING WAS REPEATED ON SN (B)(6) RESULT = 0.55. (B)(6) 2024 SID (B)(6): EDTA TUBE USED FOR INITIAL PANTHER TESTING WAS REPEATED ON SN (B)(6) RESULT = 0.55. THE CUSTOMER ALSO RAN SID (B)(6) AND SID (B)(6) ON THE BIORAD EIA PLATFORM WITH NONREACTIVE RESULTS. THERE WAS NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HBSAG RESULTS WERE GENERATED FOR A POTENTIAL PRE-MORTEM DONOR OF ADVANCED AGE. THE CUSTOMER STATED THAT LIVER TRANSPLANTATION WAS A POSSIBILITY AND NO SPECIFIC RECIPIENT HAD BEEN IDENTIFIED, HOWEVER FURTHER EVALUATION AND CONSIDERATION FOR A POTENTIAL RECIPIENT WAS NO LONGER PURSUED AFTER RECEIPT OF THE REACTIVE RESULTS, AS THERE WERE NO SUITABLE RECIPIENTS TO RECEIVE THE LIVER FROM A DONOR OF ADVANCED AGE WITH SUSPICION/CONCERN OF HBSAG AND THEREFORE ORGAN RECOVERY WAS ABORTED. THE CUSTOMER FURTHER STATED THAT THEY WOULD HAVE CONTINUED WITH EVALUATION AND POTENTIAL FOR THIS CASE IF THE RESULTS HAD BEEN NONREACTIVE. NO NEUTRALIZING CONFIRMATORY TESTING PERFORMED FOR THE REACTIVE ALINITY S HBSAG RESULTS. NAT TESTING, BIORAD EIA, AND FURTHER REPEAT TESTING ON THE ALINITY S WERE NONREACTIVE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE = 1.0 S/CO IS REACTIVE): (B)(6) 2024 SID (B)(6): ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 1.38, 1.31, 1.39 SID E00000487: PANTHER RESULT = NONREACTIVE. (B)(6) 2024 SID (B)(6): ALINITY S HBSAG RESULT (PROCESSED ON (B)(6)) = 1.74, REPEAT RESULT = 0.59 NONREACTIVE (PROCESSED ON (B)(6)). (B)(6) 2024 SID (B)(6) : EDTA TUBE USED FOR INITIAL PANTHER TESTING WAS REPEATED ON SN (B)(6) RESULT = 0.55. (B)(6) 2024 SID (B)(6): EDTA TUBE USED FOR INITIAL PANTHER TESTING WAS REPEATED ON SN (B)(6) RESULT = 0.55. THE CUSTOMER ALSO RAN SID (B)(6) AND SID (B)(6) ON THE BIORAD EIA PLATFORM WITH NONREACTIVE RESULTS. THERE WAS NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HBSAG RESULTS WERE GENERATED FOR A POTENTIAL PRE-MORTEM DONOR OF ADVANCED AGE. THE CUSTOMER STATED THAT LIVER TRANSPLANTATION WAS A POSSIBILITY AND NO SPECIFIC RECIPIENT HAD BEEN IDENTIFIED, HOWEVER FURTHER EVALUATION AND CONSIDERATION FOR A POTENTIAL RECIPIENT WAS NO LONGER PURSUED AFTER RECEIPT OF THE REACTIVE RESULTS, AS THERE WERE NO SUITABLE RECIPIENTS TO RECEIVE THE LIVER FROM A DONOR OF ADVANCED AGE WITH SUSPICION/CONCERN OF HBSAG AND THEREFORE ORGAN RECOVERY WAS ABORTED. THE CUSTOMER FURTHER STATED THAT THEY WOULD HAVE CONTINUED WITH EVALUATION AND POTENTIAL FOR THIS CASE IF THE RESULTS HAD BEEN NONREACTIVE. NO NEUTRALIZING CONFIRMATORY TESTING PERFORMED FOR THE REACTIVE ALINITY S HBSAG RESULTS. NAT TESTING, BIORAD EIA, AND FURTHER REPEAT TESTING ON THE ALINITY S WERE NONREACTIVE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE = 1.0 S/CO IS REACTIVE): ON (B)(6) 2024, SID: (B)(6): ALINITY S HBSAG RESULTS (PROCESSED ON SN: (B)(6) = 1.38, 1.31, 1.39. SID: (B)(6): PANTHER RESULT = NONREACTIVE. ON (B)(6) 2024, SID: (B)(6): ALINITY S HBSAG RESULT (PROCESSED ON (B)(6) = 1.74, REPEAT RESULT = 0.59 NONREACTIVE (PROCESSED ON (B)(6). ON (B)(6) 2024, SID: (B)(6): EDTA TUBE USED FOR INITIAL PANTHER TESTING WAS REPEATED ON SN: (B)(6) RESULT = 0.55. ON (B)(6) 2024, SID: (B)(6): EDTA TUBE USED FOR INITIAL PANTHER TESTING WAS REPEATED ON SN: (B)(6) RESULT = 0.55. THE CUSTOMER ALSO RAN SID: (B)(6) ON THE BIORAD EIA PLATFORM WITH NONREACTIVE RESULTS. THERE WAS NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1105085 | ALINITY S HBSAG REAGENT KIT | ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (MOUSE MONOCLONAL IGG AND IGM) | QHM | ABBOTT IRELAND DIAGNOSTICS DIVISION | 54640FN00 | 00380740136819 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Disability | ALNTY S SYSTEM, 06P16-01, (B)(6).| ALNTY S SYSTEM, 06P16-01, (B)(6).| ALNTY S SYSTEM, 06P16-01, (B)(6). |