ALINITY S HBSAG REAGENT KIT
Report
- Report Number
- 3008344661-2024-00109
- Event Type
- Malfunction
- Date Received
- September 3, 2024
- Date of Event
- June 6, 2024
- Report Date
- December 13, 2024
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- QHM
- UDI-DI
- 00380740136819
- PMA / PMN Number
- BL 125674
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 RETURNED SPECIMENS WAS PERFORMED. THE ASSESSMENT WAS PERFORMED BY APPLYING THE VISUAL INSPECTION REFERENCE GUIDE OF THE AMERICAN RED CROSS BIOMEDICAL SERVICES. PER THE AMERICAN AND EUROPEAN RED CROSS STANDARDS, THE ACCEPTABLE LEVEL OF HEMOLYSIS (BASED ON VISUAL/QUALITATIVE INSPECTION) IS LESS THAN 0.8%. AS SUMMARIZED BELOW, THE SPECIMENS ARE WITHIN THE ACCEPTABLE LEVEL OF HEMOLYSIS PER THE AMERICAN AND EUROPEAN RED CROSS STANDARDS. SAMPLE ID / LEVEL OF HEMOLYSIS: (B)(6) / 0.2 %, (B)(6) / 0.40 %, (B)(6) / 0.10%, (B)(6) / 0.10 %, (B)(6) / 0.10 %, (B)(6) / 0.50 %. ADDITIONALLY, TO ASSESS THE LEVEL OF CELLULAR DEBRIS, THE RETURNED SPECIMENS WERE ANALYZED WITH THE AID OF A MICROSCOPE AND HEMACYTOMETER. VARYING LEVELS OF PARTICULATE MATTER WERE OBSERVED IN EACH SPECIMEN. 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 SPECIMENS WAS PERFORMED. THE FOLLOWING TABLE SUMMARIZES THE CELL-DYN SAPPHIRE HEMOGLOBIN TESTING ON THE RETURNED SPECIMENS. 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). SAMPLE ID / HEMOGLOBIN (MG/DL): (B)(6) / 170 MG/DL, (B)(6) / 192 MG/DL, (B)(6) / 96 MG/DL, (B)(6) / 102 MG/DL, (B)(6) / 103 MG/DL, (B)(6) / 358 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 (B)(4). THE FOLLOWING TABLE SUMMARIZES THE ALINITY S HBSAG TESTING ON THE RETURNED SPECIMENS. SAMPLE ID / SAMPLE TYPE / S/CO VALUES / HBSAG INTERPRETATION / ALINITY S HBSAG CONFIRMATORY (IF APPLICABLE) (B)(6) / POST-MORTEM TISSUE / 0.40 / NONREACTIVE, (B)(6) / POST-MORTEM TISSUE / 0.87 / NONREACTIVE, (B)(6) / POST-MORTEM TISSUE / 1.18, 1.08, 1.08 / REPEAT REACTIVE, (B)(6) / POST-MORTEM TISSUE / 1.05, 1.07, 1.06 / REPEAT REACTIVE, (B)(6) / PRE-MORTEM TISSUE / 1.05, 1.09, 1.08 / REPEAT REACTIVE / NOT CONFIRMED, (B)(6) / POST-MORTEM TISSUE / 0.67 / NONREACTIVE. A REVIEW OF FIELD DATA FOR ALINITY S HBSAG WAS PERFORMED. OVERALL REACTIVE RATES OF LN 6P02-60 LOT 54640FN00 ACROSS (B)(6) HOSPITAL (B)(6), 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 (B)(6) HOSPITAL (B)(6) PEER SITES IS WITHIN PACKAGE INSERT REPRESENTATIVE DATA CONFIDENCE INTERVAL OF 93.51 -100.00 FOR CADAVERIC SPECIMENS. THE SPECIFICITY AT (B)(6) HOSPITAL (B)(6) WAS OUTSIDE OF THIS CONFIDENCE INTERVAL, 231 AND 81 SAMPLES HAD BEEN TESTED AT THE TIME OF THE REVIEW. (B)(6) HOSPITAL (B)(6) 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 (B)(6) HOSPITAL (B)(6) 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.
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. COMPLETE INFORMATION FOR SECTION A1 PATIENT IDENTIFIER, SID (B)(6).
THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HBSAG RESULTS ON 4 CADAVERIC PATIENTS. SAMPLE 3 WAS ALSO RETESTED USING A PRE-MORTEM SAMPLE WITH REACTIVE RESULTS ON THE ALINITY, NO NEUTRALIZING CONFIRMATORY TESTING PERFORMED FOR THE REACTIVE ALINITY S HBSAG RESULTS ON THE PRE-MORTEM SAMPLE. NAT AND BIORAD EIA WERE NEGATIVE FOR ALL SAMPLES. FURTHER TESTING ON THE ALINITY HAD MIXED REACTIVE AND NONREACTIVE RESULTS. TISSUE SAMPLES WERE DISCARDED FOR ALL 4. THE FOLLOWING DATA WAS PROVIDED (REFERENCE = 1.0 S/CO IS REACTIVE): SAMPLE 1 TESTING: ON (B)(6) 2024, SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 2.32, 2.03, 1.90, 2.10, 2.40. ON (B)(6) ,2024 SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 1.23, REPEAT RESULT = 0.82 (PROCESSED ON (B)(6). BIORAD EIA RESULT = NONREACTIVE. SID (B)(6), (EDTA SAME PATIENT AS SID(B)(6): PANTHER RESULT = NONREACTIVE. SAMPLE 2 TESTING: ON (B)(6) 2024, SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6) = 1.90, 1.89, 2.17 ON (B)(6)2024, SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6) = 1.59, REPEAT RESULT = 0.89 (PROCESSED ON (B)(6). BIORAD EIA RESULT = NONREACTIVE. SID (B)(6), (EDTA SAME PATIENT AS SID(B)(6): PANTHER RESULT = NONREACTIVE. SAMPLE 3 TESTING: ON (B)(6)2024, SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6) = 3.38, 3.12, 2.98. ON (B)(6) 2024, SID (B)(6), (EDTA SAME PATIENT(PRE-MORTEM) AS SID(B)(6): ALINITY S HBSAG. RESULTS (PROCESSED ON SN (B)(6) = 3.35, 3.33, 3.50. ON (B)(6)2024, SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6) = 3.22, REPEAT RESULT = 1.07 (PROCESSED ON (B)(6). BIORAD EIA RESULT = NONREACTIVE. ON (B)(6) 2024, SID (B)(6), (EDTA SAME PATIENT(PRE-MORTEM) AS SID(B)(6): ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6) = 3.32, REPEAT RESULT = 1.2 (PROCESSED ON (B)(6). BIORAD EIA RESULT = NONREACTIVE. SID (B)(6), (EDTA SAME PATIENT AS SID(B)(6): PANTHER RESULT = NONREACTIVE SID (B)(6), (EDTA SAME PATIENT(PRE-MORTEM) AS SID(B)(6): ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6) = 3.07, REPEAT RESULT = 0.99 (PROCESSED ON (B)(6). PANTHER RESULT = NONREACTIVE. BIORAD EIA RESULT = NONREACTIVE. SAMPLE 4 TESTING: ON (B)(6) 2024, SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6) = 1.63, 1.53,1.58 ON (B)(6) 2024, SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6) = 2.78, REPEAT RESULT = 1.31 (PROCESSED ON (B)(6). BIORAD EIA RESULT = NONREACTIVE. SID (B)(6), (EDTA SAME PATIENT AS SID(B)(6): PANTHER RESULT = NONREACTIVE THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HBSAG RESULTS ON 4 CADAVERIC PATIENTS. SAMPLE 3 WAS ALSO RETESTED USING A PRE-MORTEM SAMPLE WITH REACTIVE RESULTS ON THE ALINITY, NO NEUTRALIZING CONFIRMATORY TESTING PERFORMED FOR THE REACTIVE ALINITY S HBSAG RESULTS ON THE PRE-MORTEM SAMPLE. NAT AND BIORAD EIA WERE NEGATIVE FOR ALL SAMPLES. FURTHER TESTING ON THE ALINITY HAD MIXED REACTIVE AND NONREACTIVE RESULTS. TISSUE SAMPLES WERE DISCARDED FOR ALL 4. THE FOLLOWING DATA WAS PROVIDED(REFERENCE = 1.0 S/CO IS REACTIVE): SAMPLE 1 TESTING: (B)(6) 2024 SID (B)(6) (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 2.32, 2.03, 1.90, 2.10, 2.40. (B)(6) 2024 SID (B)(6) (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 1.23, REPEAT RESULT = 0.82 (PROCESSED ON (B)(6)). BIORAD EIA RESULT = NONREACTIVE. SID (B)(6) (EDTA SAME PATIENT AS SID (B)(6)): PANTHER RESULT = NONREACTIVE. SAMPLE 2 TESTING: (B)(6) 2024 SID (B)(6) (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 1.90, 1.89, 2.17 (B)(6) 2024 SID (B)(6) (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 1.59, REPEAT RESULT = 0.89 (PROCESSED ON (B)(6)). BIORAD EIA RESULT = NONREACTIVE. SID (B)(6) (EDTA SAME PATIENT AS SID (B)(6)): PANTHER RESULT = NONREACTIVE. SAMPLE 3 TESTING: (B)(6) 2024 SID (B)(6) (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 3.38, 3.12, 2.98 (B)(6) 2024 SID (B)(6) (EDTA SAME PATIENT(PRE-MORTEM) AS SID (B)(6)): ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 3.35, 3.33, 3.50. (B)(6) 2024 SID (B)(6) (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 3.22, REPEAT RESULT = 1.07 (PROCESSED ON (B)(6)). BIORAD EIA RESULT = NONREACTIVE (B)(6) 2024 SID (B)(6) (EDTA SAME PATIENT(PRE-MORTEM) AS SID (B)(6)): ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 3.32, REPEAT RESULT = 1.2 (PROCESSED ON (B)(6)). BIORAD EIA RESULT = NONREACTIVE. SID (B)(6) (EDTA SAME PATIENT AS SID (B)(6)): PANTHER RESULT = NONREACTIVE SID (B)(6) (EDTA SAME PATIENT(PRE-MORTEM) AS SID (B)(6)): ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 3.07, REPEAT RESULT = 0.99 (PROCESSED ON (B)(6)). PANTHER RESULT = NONREACTIVE. BIORAD EIA RESULT = NONREACTIVE. SAMPLE 4 TESTING: (B)(6) 2024 SID (B)(6)(SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 1.63, 1.53,1.58 (B)(6) 2024 SID (B)(6) (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 2.78, REPEAT RESULT = 1.31 (PROCESSED ON (B)(6)). BIORAD EIA RESULT = NONREACTIVE. SID (B)(6) (EDTA SAME PATIENT AS SID (B)(6)): PANTHER RESULT = NONREACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 735156 | 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 | ALNTY S SYSTEM, 06P16-01, (B)(6)| ALNTY S SYSTEM, 06P16-01, (B)(6) |