ALINITY I HIV AG/AB COMBO REAGENT KIT

Report

Report Number: 3002809144-2025-00219
Event Type: Malfunction
Date Received: July 7, 2025
Date of Event: May 22, 2025
Report Date: July 11, 2025
Manufacturer: ABBOTT GMBH
Product Code: MZF
UDI-DI: 00380740121785
PMA / PMN Number: N/A
Report Source: Manufacturer report
Reporter Location: TU
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = SAMPLE ID (B)(6), SAMPLE ID (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P07-32, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08P07-31, AND A PMA NUMBER OF P090080.

Additional Manufacturer Narrative · 0

FIELD H4 - DEVICE MFG DATE UPDATED FROM 2024-12-12 TO 2024-12-10. THE COMPLAINT INVESTIGATION FOR FALSE REACTIVE ALINITY I HIV AG/AB COMBO RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. A REVIEW OF TRACKING AND TRENDING FOR THE PRODUCTS AND THE LIKELY CAUSE LOTS 70212BE00 AND 71583BE00 DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. HOWEVER, A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 70197BE00, HOWEVER, NO INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR LIST NUMBER 08P07. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE OVERALL PERFORMANCE OF THE ALINITY I HIV AG/AB COMBO REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE NUMBER OF STANDARD DEVIATIONS TO CUT-OFF FOR THE NEGATIVE POPULATION AND THE PATIENT MEDIAN VALUES OBTAINED WITH THE COMPLAINT LOT ARE WITHIN ESTABLISHED LIMITS AND THUS COMPARABLE TO THE HISTORICAL LOT PERFORMANCE, WHICH CONFIRMS NO SYSTEMIC ISSUE FOR THE LOTS. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOTS WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. AN INVESTIGATION DETERMINED THAT THIS ADVERSE EVENT REPRESENTS A CORRECT USE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I HIV AG/AB COMBO, LOT NUMBERS 70197BE00, 70212BE00 AND 71583BE00, WAS IDENTIFIED.

Description of Event or Problem · 0

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I HIV AG/AB COMBO RESULTS FOR A PREGNANT PATIENT. THE FOLLOWING DATA WAS PROVIDED (>/=1.00 S/CO IS REACTIVE): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2025 WITH ANALYZER SERIAL NUMBER (B)(6) AND LOT NUMBER 70212BE00, WAS 46.90, REPEAT RESULT WAS 50.78 S/CO. THE PATIENT WAS RECOLLECTED, UNDER SAMPLE ID (B)(6), AND THE RESULTS, WITH LOT NUMBER 70197BE00, WERE 55.15 AND 56.25 S/CO. THE SAMPLES WERE REPEATED USING ANALYZER SERIAL NUMBER (B)(6) WITH LOT NUMBER 71583BE00 AND SAMPLE ID (B)(6) WAS 58.54 S/CO AND SAMPLE ID B)(6) WAS 60.94 S/CO. THE PATIENT WAS RECOLLECTED ON (B)(6) 2025 UNDER SAMPLE ID (B)(6) AND THE RESULT, ON ANALYZER SERIAL NUMBER (B)(6) WITH LOT NUMBER 71583BE00, WAS 48.17 S/CO. THE PATIENT WAS RECOLLECTED, UNDER SAMPLE ID (B)(6), AND THE RESULT, ON ANALYZER SERIAL NUMBER (B)(6) WITH LOT NUMBER 71583BE00, WAS 42.22 S/CO. THE SAMPLE WAS SENT TO ANOTHER LAB FOR TESTING USING ELISA WITH VIDAS BIOMERIEUX AND THE RESULT WAS NEGATIVE. THE SAMPLE WAS TESTED WITH BIO-RAD GEENIUS HIV-1/2 SUPPLEMENTAL ASSAY AND SIEMENS-ADVIA CENTAUR XP AND THE RESULTS WERE NEGATIVE. THE HIV-1 RNA PCR RESULT WAS NEGATIVE. THE PATIENT GAVE BIRTH AND BASED ON THE HIV RESULTS, THE NEONATE WAS GIVEN ANTIVIRAL TREATMENT AND BREASTFEEDING WAS PROHIBITED. THERE WAS NO FURTHER PATIENT IMPACT REPORTED.

Description of Event or Problem · 0

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I HIV AG/AB COMBO RESULTS FOR A PREGNANT PATIENT. THE FOLLOWING DATA WAS PROVIDED (>/=1.00 S/CO IS REACTIVE): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2025 WITH ANALYZER SERIAL NUMBER (B)(6) AND LOT NUMBER 70212BE00, WAS 46.90, REPEAT RESULT WAS 50.78 S/CO. THE PATIENT WAS RECOLLECTED, UNDER SAMPLE ID (B)(6), AND THE RESULTS, WITH LOT NUMBER 70197BE00, WERE 55.15 AND 56.25 S/CO. THE SAMPLES WERE REPEATED USING ANALYZER SERIAL NUMBER (B)(6) WITH LOT NUMBER 71583BE00 AND SAMPLE ID (B)(6) WAS 58.54 S/CO AND SAMPLE ID (B)(6) WAS 60.94 S/CO. THE PATIENT WAS RECOLLECTED ON (B)(6) 2025 UNDER SAMPLE ID (B)(6) AND THE RESULT, ON ANALYZER SERIAL NUMBER (B)(6) WITH LOT NUMBER 71583BE00, WAS 48.17 S/CO. THE PATIENT WAS RECOLLECTED, UNDER SAMPLE ID (B)(6), AND THE RESULT, ON ANALYZER SERIAL NUMBER (B)(6) WITH LOT NUMBER 71583BE00, WAS 42.22 S/CO. THE SAMPLE WAS SENT TO ANOTHER LAB FOR TESTING USING ELISA WITH VIDAS BIOMERIEUX AND THE RESULT WAS NEGATIVE. THE SAMPLE WAS TESTED WITH BIO-RAD GEENIUS HIV-1/2 SUPPLEMENTAL ASSAY AND SIEMENS-ADVIA CENTAUR XP AND THE RESULTS WERE NEGATIVE. THE HIV-1 RNA PCR RESULT WAS NEGATIVE. THE PATIENT GAVE BIRTH AND BASED ON THE HIV RESULTS; THE NEONATE WAS GIVEN ANTIVIRAL TREATMENT AND BREASTFEEDING WAS PROHIBITED. THERE WAS NO FURTHER PATIENT IMPACT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
141677	ALINITY I HIV AG/AB COMBO REAGENT KIT	TEST, HIV DETECTION	MZF	ABBOTT GMBH		71583BE00	00380740121785

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female	Other	ALNTY I HIV COMBO 1200T, 08P07-32, 70212BE00\| ALNTY I HIV COMBO 1200T, 08P07-32, 70212BE00\| ALNTY I HIV COMBO 200T, 08P07-22, 70197BE00\| ALNTY I HIV COMBO 200T, 08P07-22, 70197BE00\| ALNTY I PROCESSING MODU, 03R65-01, (B)(6) \| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).\| ALNTY I PROCESSING MODU, 03R65-01, (B)(6.\| ALNTY I PROCESSING MODU, 03R65-01,(B)(6).