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

Catalog Number 08P07-22

Device Problem False Negative Result (1225)

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

Event Date 07/12/2023

Event Type  malfunction  

Event Description

The customer stated that nonreactive alinity i hiv ag/ab combo results were generated for one patient that tested reactive using alternate methods.The following data was provided.Sample id and date not provided.Roche cobas e411 hiv result: 20.2 coi (reactive).Roche cobas 8000 hiv result: 42.49 coi (reactive).Rapid test: reactive.(b)(6) 2023: alinity i hiv ag/ab combo result: 0.51 s/co (nonreactive).(b)(6) 2023: alinity i hiv ag/ab combo result: 0.50 s/co (nonreactive).(b)(6) 2023: sid (b)(6).Alinity i hiv ag/ab combo result: 0.48 s/co (nonreactive).Sid (b)(6).Alinity i hiv ag/ab combo results: 0.64 and 0.43 s/co (nonreactive).The same patient tested repeatedly nonreactive with the alinity i hiv ag/ab combo assay.Since other methods were reactive, the alinity results are being questioned as potentially false nonreactive.No impact to patient management was reported.

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 were generated for one patient that tested reactive using alternate methods.The following data was provided.Sample id and date not provided roche cobas e411 hiv result: 20.2 coi (reactive) roche cobas 8000 hiv result: 42.49 coi (reactive) rapid test: reactive july 12, 2023 alinity i hiv ag/ab combo result: 0.51 s/co (nonreactive) july 12, 2023 alinity i hiv ag/ab combo result: 0.50 s/co (nonreactive) july 14, 2023 sid (b)(6) alinity i hiv ag/ab combo result: 0.48 s/co (nonreactive) sid (b)(6) alinity i hiv ag/ab combo results: 0.64 and 0.43 s/co (nonreactive) the same patient tested repeatedly nonreactive with the alinity i hiv ag/ab combo assay.Since other methods were reactive, the alinity results are being questioned as 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 generated 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.Based on the investigation, no deficiency for lot number 48503be00 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: 17446819
• MDR Text Key: 320297234
• Report Number: 3002809144-2023-00341
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Catalogue Number: 08P07-22
• Device Lot Number: 48503BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2023
• 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, AI03406; ALNTY I PROCESSING MODU, 03R65-01, AI03406; ALNTY I PROCESSING MODU, 03R65-01, AI03439; ALNTY I PROCESSING MODU, 03R65-01, AI05010