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

Catalog Number 08P07-77

Device Problem False Negative Result (1225)

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

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The customer stated that nonreactive alinity i hiv ag/ab combo results of 0.07, 0.02 and 0,01 s/co were generated on (b)(6)2023 for a 57 year old male patient diagnosed with lung cancer.Testing using an alternate method was negative.The patient previously tested reactive at 824.03 s/co in (b)(6) 2022 and testing using the roche and autobio hiv methods at that time was also reactive.Western blot testing was inconclusive at that time.The patient's hiv p24 antigen result was positive in (b)(6)2022 (416.87 s/co) and in (b)(4) 2023 (14.08 s/co).The customer is concerned that the results from (b)(6)2023 are potentially false nonreactive.No impact to patient management was reported.

Manufacturer Narrative

Trending review determined no trend for the issue for the product.Historical complaint review determined there is normal complaint activity for the lot number.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.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.No malfunction was identified since non-reactive alinity i hiv ag/ab combo results were in agreement with the negative colloidal gold result.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.Note: previous samples of the patient showed reactive results, however a decrease over time can be observed (aug-2022 824.03 s/co; sep-2022 416.87 s/co and feb-2023 14.08 s/co).Potential cause for this could be antiretroviral treatment (art).However, according to complaint info the patient reduced the art.Based on the investigation, no deficiency for lot number 44554be01 was identified.

• 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: 16726190
• MDR Text Key: 313662495
• Report Number: 3002809144-2023-00188
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2023
• Device Catalogue Number: 08P07-77
• Device Lot Number: 44554BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Age: 57 YR
• Patient Sex: Male