MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT ANTI-HCV REAGENT KIT; ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS

Catalog Number	01L79-25
Medical Device Problem Codes	False Positive Result (1227); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued information for section h9: 3002809144-03/07/2024-001-c additional product information for section d and h: d4 lot #: 52011be00 d4 expiration date: 03/05/2024 d4 udi: (b)(4)h4 device mfg date: 04/26/23 d4 lot #: 54140be00 d4 expiration date: 05/22/2024 d4 udi:(b)(4).H4 device mfg date: 07/13/2023 d4 lot#: 56375be00 d4 expiration date: 07/28/2024 d4 udi: (b)(4) h4 device mfg date: 09/19/2023 d4 lot#: 58163be00 d4 expiration date: 09/23/2024 d4 udi: (b)(4).H4 device mfg date: 10/31/2023 d4 lot#: 59194be00 d4 expiration date: 10/27/2024 d4 udi: (b)(4).H4 device mfg date: 12/29/2023 d4- catalog# 01l79-35 d4 lot#: 52015be00 d4 expiration date: 05/05/2024 d4 udi: (b)(4) h4 device mfg date: 04/26/2023 d4- catalog# 01l79-35 d4 lot#: 54144be00 d4 expiration date: 05/22/2024 d4 udi: (b)(4) h4 device mfg date: 07/18/2023 d4- catalog# 01l79-35 d4 lot#: 56379be00 d4 expiration date: 07/28/2024 d4 udi:(b)(4).H4 device mfg date: 09/19/2023 d4- catalog# 01l79-35 d4 lot#: 58167be00 d4 expiration date: 09/23/2024 d4 udi: ((b)(4) h4 device mfg date: 10/31/2023 d4- catalog# 01l79-35 d4 lot#: 59198be00 d4 expiration date: 10/27/2024 d4 udi:(b)(4).H4 device mfg date: 12/28/2023 d1 brand name: alinity i anti-hcv reagent kit d4- catalog# 08p05-21 d4 lot#: 52020be00 d4 expiration date: 03/05/2024 d4 udi:(b)(4).H4 device mfg date: 05/04/2023 d1 brand name: alinity i anti-hcv reagent kit d4- catalog# 08p05-21 d4 lot#: 54149be00 d4 expiration date: 05/22/2024 d4 udi: (b)(4).H4 device mfg date: 07/17/2023 d1 brand name: alinity i anti-hcv reagent kit d4- catalog# 08p05-21 d4 lot#: 56384be00 d4 expiration date: 07/28/2024 d4 udi: (b)(4).H4 device mfg date: 09/28/2023 d1 brand name: alinity i anti-hcv reagent kit d4- catalog# 08p05-21 d4 lot#: 58172be00 d4 expiration date: 09/23/2024 d4 udi: (b)(4).H4 device mfg date: 11/06/2023 d1 brand name: alinity i anti-hcv reagent kit d4- catalog# 08p05-21 d4 lot#: 59203be00 d4 expiration date: 10/27/2024 d4 udi:(b)(4).H4 device mfg date: 01/02/2024 note: only in date lots are listed.All future lots of architect and alinity i anti-hcv reagent are impacted.Investigation into this issue found the root cause for the reagent cross contamination (rcc) was determined to be a non-specific interaction of the non-fat dry milk (nfdm) present in the assay specific diluent (asd) of architect and alinity i syphilis tp as well as architect advisedx sars-cov-2-igg ii.Nfdm is carried over through the reagent pipettor.Current reagent pipettor washing is not fully capable to remove the nfdm.The nfdm-mediated rcc was reduced upon increasing reagent pipettor washing after use of the architect advisedx sars-cov-2 igg ii assay, and prior to use of the architect and alinity i anti-hcv assay when preceded by the architect and alinity i syphilis tp assay or architect advisedx sars-cov-2 igg ii assay.Note: architect and alinity i anti-hcv share the same reagent formulation.A product correction letter was issued on 04mar2024 to all architect anti-hcv customers who have in-dating architect anti-hcv reagent kits in their laboratory and are using architect syphilis tp and/ or architect advisedx sars-cov-2 igg ii as well and all alinity i anti-hcv customers who have in-dating alinity i anti-hcv reagent kits in their laboratory and are using alinity i syphilis tp as well notifying them of the potential issue and impact on patient results.The letter informs the customer that the assay files for the architect anti-hcv assay (ln 1l79) and alinity i anti-hcv assay (ln 08p05) were updated to include a pre-wash of the reagent pipettor prior to the aspiration; and, the assay file for architect advisedx sars-cov-2-igg ii assay (ln 6s60) was updated to increase wash volumes of the reagent pipettor washing after use.Additionally, the product correction letter instructs the customer to install the most current assay file version(s) of the assay(s) used by the laboratory.Installation of the new assay file version will require new calibration as per the architect system/alinity ci series operations manual.The customer is instructed to deplete the current on-board architect anti-hcv, architect advicedx sars-cov-2-igg ii and alinity i anti-hcv reagent kits before installing the new assay file versions and perform a manual backup.
Event or Problem Description
Abbott has identified a potential issue for architect anti-hcv and alinity i anti-hcv reagent kits.Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: ¿architect syphilis tp (list number 08d06) and or architect advisedx sars-cov-2-igg ii (list number 06s60) precedes architect anti-hcv testing (list number 01l79).¿alinity i syphilis tp (list number 07p60) precedes alinity i anti-hcv testing (list number 08p05).There is potential for false elevation of patient results, including nonreactive to grayzone, grayzone to reactive and non-reactive to reactive architect and alinity i anti-hcv patient results when architect syphilis tp/ architect advisedx sars-cov-2-igg ii or alinity i syphilis tp precedes anti-hcv testing.Although potential interactions may cause false elevation of results for some patient samples, further studies including a randomized sample population showed that the required performance specifications including specificity of the architect and alinity i anti-hcv assays were met.The customers who do not utilize both the architect anti-hcv and architect syphilis tp and or architect anti-hcv and architect advisedx sars-cov-2-igg ii reagent kits are not impacted by this issue.There has been no reported delay of results or adverse impact to patient management as a result of this issue.

• Brand Name: ARCHITECT ANTI-HCV REAGENT KIT
• Common Device Name: ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS
• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18876387
• Report Number: 3002809144-2024-00033
• Device Sequence Number: 18122722
• Product Code: MZO
• UDI-Device Identifier: 00380740001414
• UDI-Public: 00380740001414
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P050042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 01L79-25
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3002809144-03/07/2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALINITY I SYPHILIS TP REAGENT KIT, LN 07P60; ARCHITECT ADVISEDX SARS-COV-2-IGG II, LN 06S60; ARCHITECT SYPHILIS TP REAGENT KIT, LN 08P06
• Patient Sex: Unknown