ALINITY I HIV AG/AB COMBO REAGENT KIT
Report
- Report Number
- 3002809144-2025-00174
- Event Type
- Malfunction
- Date Received
- June 2, 2025
- Date of Event
- May 9, 2025
- Report Date
- June 4, 2025
- Manufacturer
- ABBOTT GMBH
- Product Code
- MZF
- UDI-DI
- 00380740121761
- PMA / PMN Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P07-22 / 32 / 74 / 77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P07-21 / 31, WITH 510K/PMA/BLA NUMBER P090080. COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
THE COMPLAINT EVALUATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, IN-HOUSE TESTING OF ALINITY I HIV AG/AB COMBO REAGENT LOT 69155BE00. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I HIV AG/AB COMBO ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 69155BE00. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH LOT NUMBER 69155BE00. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE LOT 69168BE00 WHICH CONTAINS THE SAME BULK REAGENTS AS THE COMPLAINT LOT 69155BE00 WAS PERFORMED. ALL SPECIFICATIONS WERE MET AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED, SHOWING THAT THE LOT GENERATES THE EXPECTED RESULTS. IN ADDITION, THE CLINICAL SENSITIVITY OF THE LOT WAS EVALUATED BY TESTING ONE COMMERCIALLY AVAILABLE SEROCONVERSION PANEL (ZEPTOMETRIX HIV 9013). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO ARCHITECT HIV AG/AB COMBO TEST RESULTS PROVIDED BY ZEPTOMETRIX AND THE REAGENT LOT DETECTED THE SAME BLEEDS AS REACTIVE. BASED ON THESE DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE OF THE COMPLAINT LOT IS NOT ADVERSELY AFFECTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I HIV AG/AB COMBO REAGENT, LOT 69155BE00.
THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I HIV RESULTS ON A PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6), INITIAL=0.38 S/CO (< 1.00 S/CO=NONREACTIVE) /RECENTRIFUGED AND REPEATED=1.64 S/CO (> OR = 1.00 S/CO=REACTIVE) THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I HIV RESULTS ON A PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6), INITIAL=0.38 S/CO (< 1.00 S/CO=NONREACTIVE) /RECENTRIFUGED AND REPEATED=1.64 S/CO (> OR = 1.00 S/CO=REACTIVE) THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1462321 | ALINITY I HIV AG/AB COMBO REAGENT KIT | TEST, HIV DETECTION | MZF | ABBOTT GMBH | 69155BE00 | 00380740121761 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6) |