ALINITY M RESP-4-PLEX AMP KIT
Report
- Report Number
- 3005248192-2023-00213
- Event Type
- Malfunction
- Date Received
- August 22, 2023
- Date of Event
- May 13, 2022
- Report Date
- September 26, 2023
- Manufacturer
- ABBOTT MOLECULAR, INC.
- Product Code
- QJR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
ELEVATED COMPLAINT INVESTIGATION WILL BE INITIATED. AS THE EVENT OCCURRED OVER MULTIPLE RUN DATES, THE FOLLOWING ADDITIONAL MDRS WILL ALSO BEEN SUBMITTED: 3005248192-2023-00214, 3005248192-2023-00215, 3005248192-2023-00216, 3005248192-2023-00217, 3005248192-2023-00218, 3005248192-2023-00219, 3005248192-2023-00220, 3005248192-2023-00221, 3005248192-2023-00222, 3005248192-2023-00223, 3005248192-2023-00224, 3005248192-2023-00225, 3005248192-2023-00226, 3005248192-2023-00227.
INVESTIGATION INTO THIS COMPLAINT INCLUDED A RETAIN EVALUATION, A CUSTOMER DATA REVIEW, QUALITY DATA REVIEW, AND A COMPLAINT HISTORY REVIEW FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-096) LOTS 524433, 526710, 381817, AND 382958. THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED AS FOLLOWS: RETAIN EVALUATION: THE RETAIN FILE SAMPLE EVALUATION FOR THE ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-096) LOT 381817 AND 382958 WAS PERFORMED. NO ERROR CODES WERE PRESENTED DURING TESTING AND ALL TESTING REPLICATES WERE INTERPRETED CORRECTLY BY THE ASSAY SOFTWARE. THE FILE SAMPLE EVALUATION FOR LOT 381817 AND 382958 MET THE ACCEPTANCE CRITERIA AND VALIDITY CRITERIA THAT WERE ESTABLISHED FOR THE RESP-4-PLEX FALSE POSITIVE TESTING PROTOCOL. AS A RESULT, THE PRODUCT FILE SAMPLE EVALUATION FOR THE ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-096) LOT 381817 AND 382958 RECEIVED A DISPOSITION OF PASSED. FILE SAMPLE TESTING FOR LOT 522443 AND 526710 WAS NOT PERFORMED. CUSTOMER DATA REVIEW: REVIEW OF THE CUSTOMER DATA WAS PERFORMED. THE RUNS WHICH INVOLVED THE DISCREPANT RESULTS WERE VALID AND MET ASSAY SPECIFICATION REQUIREMENTS, AND NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE CONTROLS. THE DISCREPANT RESULTS PRODUCED VALID RESULTS, AND THE AMPLIFICATION CURVES DID NOT APPEAR ABNORMAL. QUALITY DATA REVIEW: DEVICE HISTORY RECORD / BATCH RECORD REVIEW REVIEW OF THE MANUFACTURING PACKET FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-096) LOTS 524433, 526710, 381817, AND 382958 (INCLUDING THE COMPONENTS) DID NOT IDENTIFY ANY ISSUES WHICH COULD RESULT IN THE REPORTED COMPLAINT. NO ISSUES WERE FOUND DURING QUALITY CONTROL (QC) TESTING. THE QC AMP KIT MASTERLOT TESTING MET ALL ACCEPTANCE AND VALIDITY SPECIFICATION CRITERIA. CAPA / NON-CONFORMANCE REVIEW: A CAPA REVIEW WAS PERFORMED TO IDENTIFY ANY RECORDS THAT WERE POTENTIALLY RELATED TO THE REPORTED COMPLAINT FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-096) LOTS 524433, 526710, 381817, AND 382958 AND THEIR COMPONENTS. THIS CAPA REVIEW DID NOT IDENTIFY ANY EXISTING INTERNAL ISSUES OR NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY RECORDS THAT WERE POTENTIALLY RELATED TO THE REPORTED COMPLAINT FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-096) LOTS 524433, 526710, 381817, AND 382958 AND THEIR COMPONENTS. A PRODUCT DEFICIENCY WAS NOT DETERMINED BY THIS EVALUATION FOR THE REPORTED COMPLAINT. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR THE ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-096) LOTS 524433, 526710, 381817, AND 382958 WAS NOT CONFIRMED. AS THE EVENT OCCURRED OVER MULTIPLE RUN DATES, THE FOLLOWING MDRS WERE SUBMITTED: 3005248192-2023-00212 3005248192-2023-00213 3005248192-2023-00214 3005248192-2023-00215 3005248192-2023-00216 3005248192-2023-00217 3005248192-2023-00218 3005248192-2023-00219 3005248192-2023-00220 3005248192-2023-00221 3005248192-2023-00222 3005248192-2023-00223 3005248192-2023-00224 3005248192-2023-00232 3005248192-2023-00233 3005248192-2023-00234 3005248192-2023-00235.
UPDATES: B5 - CLARIFIED SID RUN ON EVENT DATE. D4 - ADDED LOT NUMBER, EXPIRATION DATE AND UDI. H4 - ADDED DEVICE MANUFACTURE DATE.
THE CUSTOMER REPORTED THAT THEY WERE SEEING FALSE DETECTED ALINITY M RESP-4-PLEX RESULTS. WHEN REPEATED ON EITHER THE ALINITY ASSAY OR THE CEPHEID GENEEXPERT SYSTEM A NOT DETECTED RESULT IS GENERATED. THE FOLLOWING 26 SAMPLE IDS (SIDS) WERE PROVIDED BY THE CUSTOMER AS AN EXAMPLE OF THEIR CONCERN. ALL QUESTIONED SIDS HAVE A LATE CYCLE THRESHOLD. (B)(6): SAMPLE ID (SID) (B)(6), UNID 15, REPORTED AS DETECTED FOR "FLUVID" TARGET (CT 37.67), REPEATED AND RESULT IS UNKNOWN, NOT DETECTED ON CEPHEID. (B)(6): SAMPLE ID (SID) (B)(6), UNID 111, REPORTED AS DETECTED FOR COV-2 TARGET (CT 36.25), REPEATED AND RESULT IS UNKNOWN, NOT DETECTED ON CEPHEID. (B)(6): SAMPLE ID (SID) (B)(6), UNID 116, REPORTED AS DETECTED FOR COV-2 TARGET (CT 36.52), REPEATED AND RESULT IS UNKNOWN, NOT DETECTED ON CEPHEID. SAMPLE ID (SID) (B)(6), UNID 115, REPORTED AS DETECTED FOR COV-2 TARGET (CT 37.54), REPEATED AND RESULT IS UNKNOWN, NOT DETECTED ON CEPHEID. (B)(6): SAMPLE ID (SID) (B)(6), UNID 123, REPORTED AS DETECTED FOR COV-2 TARGET (CT 37.49), REPEATED AND RESULT IS UNKNOWN, NOT DETECTED ON CEPHEID. (B)(6): SAMPLE ID (SID) (B)(6), UNID 125, REPORTED AS DETECTED FOR COV-2 TARGET (CT 37.72), REPEATED AND RESULT IS UNKNOWN, NOT DETECTED ON CEPHEID. (B)(6): SAMPLE ID (SID) (B)(6), UNID 141, REPORTED AS DETECTED FOR COV-2 TARGET (CT 36.4), REPEATED AND RESULT IS UNKNOWN, NOT DETECTED ON CEPHEID. SAMPLE ID (SID) (B)(6), UNID 142, REPORTED AS DETECTED FOR COV-2 TARGET (CT 36.64), REPEATED AS DETECTED ON REPEAT (CT 35.1), NOT DETECTED ON CEPHEID. (B)(6): SAMPLE ID (SID) (B)(6), UNID 144 REPORTED AS DETECTED FOR COV-2 TARGET (CT 37.63), REPEATED AS DETECTED ON REPEAT (CT 36.95), NOT DETECTED ON CEPHEID. (B)(6): SAMPLE ID (SID) (B)(6), UNID 149, REPORTED AS DETECTED FOR COV-2 TARGET (CT 37.61), REPEATED AND RESULT IS UNKNOWN, NOT DETECTED ON CEPHEID. (B)(6): SAMPLE ID (SID) (B)(6), UNID 15, REPORTED AS DETECTED FOR "FLUVID" TARGET (CT 37.73), NO REPEAT ON ALINITY, NOT DETECTED ON CEPHEID. SAMPLE ID (SID) (B)(6), UNID 11, REPORTED AS DETECTED FOR COV-2 TARGET (CT 37.99), NO REPEAT ON ALINITY, NOT DETECTED ON CEPHEID. (B)(6): SAMPLE ID (SID) (B)(6), UNID 2, REPORTED AS DETECTED FOR "FLUVID" TARGET (CT 38.42), REPEATED AND RESULT IS UNKNOWN, NOT DETECTED ON CEPHEID. SAMPLE ID (SID) (B)(6), UNID 18, REPORTED AS DETECTED FOR "FLUVID" TARGET (CT 37.58), NO REPEAT ON ALINITY, NOT DETECTED ON CEPHEID. SAMPLE ID (SID) (B)(6), UNID 19, REPORTED AS DETECTED FOR "FLUVID" TARGET (CT 38.08), NO REPEAT ON ALINITY, NOT DETECTED ON CEPHEID. SAMPLE ID (SID) (B)(6), UNID 17, REPORTED AS DETECTED FOR "FLUVID" TARGET (CT 38.28), NO REPEAT ON ALINITY, NOT DETECTED ON CEPHEID. (B)(6): SAMPLE ID (SID) (B)(6), UNID 10, REPORTED AS DETECTED FOR "FLUVID" TARGET (CT 37.43), REPEATED AND RESULT IS UNKNOWN, NOT DETECTED ON CEPHEID. SAMPLE ID (SID) (B)(6), UNID 25, REPORTED AS DETECTED FOR "FLUVID" TARGET (CT 37.64), NO REPEAT ON ALINITY, NOT DETECTED ON CEPHEID. (B)(6): SAMPLE ID (SID) (B)(6), UNID 6, REPORTED AS DETECTED FOR "FLUVID" TARGET (CT 39.27), REPEATED AND RESULT IS UNKNOWN, NOT DETECTED ON CEPHEID. SAMPLE ID (SID) (B)(6), UNID 27, REPORTED AS DETECTED FOR "FLUVID" TARGET (CT 38.64), REPEATED AND RESULT IS UNKNOWN, NOT DETECTED ON CEPHEID. UNKNOWN RUN DATE: SAMPLE ID (SID) (B)(6), UNID 29, REPORTED AS DETECTED FOR "FLUVID" TARGET (CT 36.6), NO REPEAT ON ALINITY, NOT REPEATED ON CEPHEID. SAMPLE ID (SID) (B)(6), UNID 28, REPORTED AS DETECTED FOR "FLUVID" TARGET (CT 36.83), NO REPEAT ON ALINITY, NOT REPEATED ON CEPHEID. SAMPLE ID (SID) (B)(6), UNID 32, REPORTED AS DETECTED FOR "FLUVID" TARGET (CT 38.01), NO REPEAT ON ALINITY, NOT REPEATED ON CEPHEID. SAMPLE ID (SID) (B)(6), UNID 23, REPORTED AS DETECTED FOR "FLUVID" TARGET (CT 38.15), NO REPEAT ON ALINITY, NOT REPEATED ON CEPHEID. SAMPLE ID (SID) (B)(6), UNID 31, REPORTED AS DETECTED FOR "FLUVID" TARGET (CT 38.25), NO REPEAT ON ALINITY, NOT REPEATED ON CEPHEID. SAMPLE ID (SID) (B)(6), UNID 47, REPORTED AS DETECTED FOR "FLUVID" TARGET (CT 38.5), NO REPEAT ON ALINITY, NOT REPEATED ON CEPHEID. THE CUSTOMER REPORTED THAT IN THEIR LAB, EVERY ALINITY M RESP-4-PLEX SAMPLE THAT COMES UP DETECTED AT A CYCLE THRESHOLD (CT) OF 36 OR HIGHER GETS REPEATED. IT WAS REPORTED THAT SOMETIMES THE SAMPLES GET REPEATED ON THE ALINITY M RESP-4-PLEX, AND SOMETIMES ON CEPHEID GENEEXPERT. THE CUSTOMER STATED THAT THEY KNOW THAT THE CEPHEID ASSAY IS LESS SENSITIVE, BUT THEY STILL BELIEVE THEY SHOULD BE GETTING A HIGHER PERCENTAGE OF REPEATS IF THESE ARE TRUE POSITIVES. THE RESULTS DID NOT IMPACT THE PATIENT MANAGEMENT.
THE CUSTOMER REPORTED 1 FALSE DETECTED ALINITY M RESP-4-PLEX RESULT. SAMPLE ID (SID) (B)(6), UNID (B)(6) REPORTED AS DETECTED FOR COV-2 TARGET (CT 37.63), REPEATED AS DETECTED ON REPEAT (CT 36.95), NOT DETECTED ON CEPHEID. THE CUSTOMER REPORTED THAT IN THEIR LAB, EVERY ALINITY M RESP-4-PLEX SAMPLE THAT COMES UP DETECTED AT A CYCLE THRESHOLD (CT) OF 36 OR HIGHER GETS REPEATED. IT WAS REPORTED THAT SOMETIMES THE SAMPLES GET REPEATED ON THE ALINITY M RESP-4-PLEX, AND SOMETIMES ON CEPHEID GENEEXPERT. THE CUSTOMER STATED THAT THEY KNOW THAT THE CEPHEID ASSAY IS LESS SENSITIVE, BUT THEY STILL BELIEVE THEY SHOULD BE GETTING A HIGHER PERCENTAGE OF REPEATS IF THESE ARE TRUE POSITIVES. THE RESULTS DID NOT IMPACT THE PATIENT MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301683 | ALINITY M RESP-4-PLEX AMP KIT | REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | QJR | ABBOTT MOLECULAR, INC. | 526710 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |