ALINITY I HIV AG/AB COMBO REAGENT KIT
Report
- Report Number
- 3002809144-2025-00172
- Event Type
- Malfunction
- Date Received
- June 2, 2025
- Date of Event
- May 14, 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
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
COMPLETE ENTRY FOR SECTION A1: PATIENT IDENTIFIER: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 08P07-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 8P07-21 / 31, WITH PMA NUMBER: P090080. 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.
CORRECTION TO H6 - ADVERSE EVENT PROBLEM FROM A090804 TO A090803. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, IN HOUSE TESTING AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. 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 70377BE00. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER. IN-HOUSE TESTING AND SENSITIVITY TESTING OF A RETAINED REAGENT KIT OF THE COMPLAINT LOT 70377BE00 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 9016). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO ARCHITECT HIV AG/AB COMBO (ALINITY I HIV AG/AB COMBO IS EQUIVALENT TO ARCHITECT HIV AG/AB COMBO AS THEY SHARE THE SAME BULK REAGENTS). THE TEST RESULTS PROVIDED BY ZEPTOMETRIX AND THE REAGENT LOT DETECTED THE SAME BLEEDS AS REACTIVE. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I HIV AG/AB COMBO REAGENT LOT 70377BE00 WAS IDENTIFIED.
THE CUSTOMER OBSERVED A FALSE NONREACTIVE ALINITY I HIV AG/AB COMBO FOR A 29-YEAR-OLD MALE. THE PATIENT HAS BEEN DIAGNOSED AS HIV POSITIVE AND HAS BEEN ON MEDICINE FOR THE LAST 2 YEARS. THE FOLLOWING RESULTS WERE PROVIDED: SID: (B)(6), INITIAL HIV RESULT= 0.07 S/CO; DUE TO PATIENT HISTORY, REPEAT RESULT WITH A FRESH SAMPLE: 1.14 S/CO; REPEAT RESULT (AFTER RECENTRIFUGATION) = 0.38 S/CO THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER OBSERVED A FALSE NONREACTIVE ALINITY I HIV AG/AB COMBO FOR A 29-YEAR-OLD MALE. THE PATIENT HAS BEEN DIAGNOSED AS HIV POSITIVE AND HAS BEEN ON MEDICINE FOR THE LAST 2 YEARS. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6), INITIAL HIV RESULT= 0.07 S/CO; DUE TO PATIENT HISTORY, REPEAT RESULT WITH A FRESH SAMPLE= 1.14 S/CO; REPEAT RESULT (AFTER RECENTRIFUGATION) = 0.38 S/CO THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642661 | ALINITY I HIV AG/AB COMBO REAGENT KIT | TEST, HIV DETECTION | MZF | ABBOTT GMBH | 70377BE00 | 00380740121761 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Male | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6) |