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

Model Number	2P36-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer observed false reactive architect hiv ag/ab combo results on a male liver transplant recipient patient.The customer also noticed discrepancy in results between heparinized sample and serum sample from the same patient.The following data was provided: heparinized sample: result = 0.5 s/co (nonreactive).Serum sample: result = 1.1 s/co, 1.2 s/co (reactive).Hiv1/2 differentiation = negative.Hiv rna pcr = negative.Previous result from one month before = 0.17 s/co (nonreactive).The patient was at the top of the list for liver transplant and surgery was scheduled.Since pretesting indicated a reactive hiv result, surgery was cancelled, and the patient did not receive the liver transplant.The customer stated the initial testing which generated a reactive result was performed by a new lab technician who did not centrifuge the sample and did not repeat to confirm the reactive result.However, discrepancy between sample types were still noted with proper handling of samples.Liver transplant surgery was cancelled.No further impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for false reactive architect hiv ag/ab combo results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, field data review, and labeling review.In-house testing of retained reagent kit was also completed.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.Ticket search by lot indicates that the reagent lot perform as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 41200be00 and complaint issue.The overall performance of the architect hiv ag/ab combo reagents in the field was review using data gathered from customers worldwide.The number of standard deviations to cutoff for the negative population and median values for the complaint lot are within the established limits and comparable to the historical reagent lot performance, which confirms no systemic issue for the lot.Labeling was reviewed and found to be adequate.In-house testing of a retained reagent kit of the complaint lot was performed.All specifications were met and no false nonreactive results were obtained.Based on the review of the issue, it was agreed by the cft (cross-functional team) consisting of medical affairs, quality and technical operation that this represents a use error.The reactive results for the serum sample might possibly be related to pre-analytical issues or sample integrity.According to the package insert of the assay, section ¿preparation for analysis¿ specimens have to be centrifuged using an appropriate tube at = 100,000 g-minutes before testing if they contain fibrin, red blood cells, or other particulate matter.Additionally, per the architect hiv ag/ab reagent package insert section ¿interpretation of results¿ an initial reactive result requires a retest in duplicate.If one or both retest results are reactive, the final result is reactive.A repeat reactive result is only presumptive evidence of hiv-1 p24 ag and/ or hiv-1/hiv-2 ab.Reactive specimens should be further tested by a supplemental method.The supplemental methods performed for the sample in question (hiv1/2 antibody differentiation and hiv rna pcr) provided negative results.Based on our investigation, no systemic issue or deficiency with the architect hiv ag/ab combo reagent for lot 41200be00 was identified.

• Brand Name: ARCHITECT HIV AG/AB COMBO REAGENT KIT
• Common Device Name: 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: 15867180
• Report Number: 3002809144-2022-00412
• Device Sequence Number: 5487274
• Product Code: MZF
• UDI-Device Identifier: 00380740003890
• UDI-Public: 00380740003890
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2023
• Device Model Number: 2P36-25
• Device Catalogue Number: 02P36-25
• Device Lot Number: 41200BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 11/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, 03M74-02, ISR06957
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Male