MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I HIV AG/AB COMBO REAGENT KIT; TEST, HIV DETECTION

Model Number 08P0721

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a false nonreactive alinity i hiv ag/ab combo result for one patient.The alinity i hiv ag/ab combo result was nonreactive for sid (b)(6), and a viral load was also ordered.The viral load result was ¿detected, 60000 copies/ml¿.The doctor then asked to retest the hiv sample on the alinity and the retest result was also nonreactive.The patient had another specimen collected 2 days later and resulted 7.55 s/co.No impact to patient management was reported.

Manufacturer Narrative

Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the reagent lot performs as expected for this product.Device history record review was performed on lot 48132be00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends.In-house testing of a retained reagent kit of the complaint lot was performed, showing that the lot generates the expected results.In addition, the clinical sensitivity of the lot was evaluated by testing two commercially available seroconversion panels (zeptometrix hiv 9013 and hiv 9016).The seroconversion panel results were compared to architect hiv test results provided by zeptometrix.The lot detected the same bleeds as reactive for the seroconversion panels.Based on these data it was shown that the sensitivity performance of the complaint lot is not adversely affected.Note: alinity i hiv ag/ab combo and architect hiv ag/ab combo utilize the same reagents and sample/reagent ratios.The returned specimen sample id (b)(6) was tested with a retained kit of alinity i hiv ag/ab combo (us) reagent lot 48132be00 and a non-reactive result (0.73 s/co) was obtained, confirming the customer¿s observation.The specimens was further tested with western blot mikrogen recomline hiv-1 & hiv-2 igg and showed a negative result; no bands were identified.Innotest hiv antigen mab testing (detects p24 antigen) provided a negative result (od 0.038, cutoff: 0.050).Note: per complaint information the customer obtained a positive viral load testing result with 60,000 copies/ml.No indication of false non-reactive results was identified, as the alinity i hiv ag/ab combo detects hiv p24 antigen and antibodies to hiv-1 and hiv-2, but not hiv rna.Labeling review concludes that the issue is adequately addressed.Note: in the early phase of an hiv infection there is a delay before detectable levels of antigens and antibodies appear.Therefore, the most likely explanation for the non-reactive test results is that the donors were in the diagnostic window below the detection limit.No malfunction was identified, as in-house testing of return sample showed non-reactive hiv antigen (innotest hiv mab) and antibody (hiv-1/hiv-2 immunoblot) results.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.

Event Description

The customer observed a false nonreactive alinity i hiv ag/ab combo result for one patient.The alinity i hiv ag/ab combo result was nonreactive for sid (b)(6), and a viral load was also ordered.The viral load result was ¿detected, 60000 copies/ml¿.The doctor then asked to retest the hiv sample on the alinity and the retest result was also nonreactive.The patient had another specimen collected 2 days later and resulted 7.55 s/co.No impact to patient management was reported.

• Brand Name: ALINITY I HIV AG/AB COMBO REAGENT KIT
• Type of Device: TEST, HIV DETECTION
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16809679
• MDR Text Key: 313949560
• Report Number: 3002809144-2023-00202
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 00380740121754
• UDI-Public: 00380740121754
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2023
• Device Model Number: 08P0721
• Device Catalogue Number: 08P07-21
• Device Lot Number: 48132BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I HIV COMBO 200 T, 08P07-21, 48132BE00; ALNTY I HIV COMBO 200 T, 08P07-21, 48132BE00