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

Catalog Number	01L79-25
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not provided.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 syphilis tp.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 prior to use of the architect anti-hcv assay when preceded by the architect syphilis tp assay.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 notifying them of the potential issue and impact on patient results.The letter informs the customer that the assay file for the architect anti-hcv assay (ln 1l79) was updated to include a pre-wash of the reagent pipettor prior to the aspiration.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 operations manual.The customer is instructed to deplete the current on-board architect anti-hcv reagent kits before installing the new assay file versions and perform a manual backup.
Event or Problem Description
The customer observed false reactive architect anti-hcv results for several patients.The following example was provided (>/=1.00 s/co is reactive): sample id (b)(6) initial result, on (b)(6), was 1.05, repeat results, on (b)(6), were 0.17 and 0.19 s/co.It was noted that right before the reactive result, a syphilis result was run, which gave a nonreactive result of 0.19.The physician questioned the reactive anti-hcv result, as it did not match the patient¿s history.There was no impact to patient management.

• 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: 19631985
• Report Number: 3002809144-2024-00184
• Device Sequence Number: 20699590
• Product Code: MZO
• UDI-Device Identifier: 00380740001414
• UDI-Public: (01)00380740001414(17)241027(10)59194BE00
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/28/2024

1 Device 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 Expiration Date: 10/27/2024
• Device Catalogue Number: 01L79-25
• Device Lot Number: 59194BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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: 3002809144-03/07/2024-00