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

Catalog Number 06C37-27

Device Problem False Negative Result (1225)

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

Event Date 03/01/2023

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.Mfr 3002809144-2023-00112-00 is for donor sample (22-year old male).Mfr 3002809144-2023-00113-00 is for recipient 1.Mfr 3002809144-2023-00114-00 is for recipient 2.

Event Description

A literature article by himmelsbach, kiyoshi, et al., ¿second hepatitis c virus transmission by blood components since introduction of mandatory nat screening in germany¿, it is documented a transfusion-transmitted (tt) episode for anti- hcv in germany since mandatory nucleic acid amplification techniques (nat) screening was introduced in 1999.The article reported a false nonreactive architect anti-hcv result for a repeat donor (male, 22 years old).The blood components of fresh frozen plasma (ffp), pool platelet concentrate (ppc), and red cell concentrate (rcc) were derived from this donation.The fresh frozen plasma (ffp) was quarantine and further testing was complete and generated a positive hcv result by the hcv rna methodology when a look back was performed, therefore the product was not transfused.However, 2 recipients of the corresponding blood products derived from the donation in february 2019, a pooled platelet concentrated (ppc) transfused on february 20, 2019, and a red cell concentrate (rcc) was transfused on march 1, 2019, were identified.One recipient was transfused with the pooled platelet concentrate (ppc) and tested positive for anti-hcv on april 24, 2019.An hcv rna concentration of 7.9 x 10^6 was obtained on may 17, 2019.The recipient transfused with red cell concentrate (rcc) tested positive for hcv rna with a concentration of 7 x 10^6 in june 2019.No data from the antigen testing and neither a sample of the initial blood draw was available from this recipient.There was no further impact to patient management reported.

Manufacturer Narrative

This report is being filed on an international product, list number 06c37 that has a similar product distributed in the us, list number 1l79.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation for false non-reactive architect anti-hcv results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.The incident along with the assay risk management files were reviewed.This review found the assay¿s risk management file were adequate and sufficiently addresses the incident.Labeling was reviewed and adequately addresses the issue under review.The device history record was reviewed and did not identify any deviations in relation to the complaint issue.A review of tracking and trending data at the time the samples were tested identified an increase in complaint activity due to specific lots of architect anti-hcv (94357li00/ 94361li00, 95367li00/ 95371li00, 94655li00 and 95522li00/ 95526li00).Studies that were conducted to investigate the increased complaint activity were reviewed.The studies consisted of sensitivity, specificity and precision studies.Each study met product requirements, and no product deficiency was identified.Based on this investigation, no systemic issue or deficiency of the architect anti-hcv assay was identified.

• Brand Name: ARCHITECT ANTI-HCV REAGENT KIT
• Type of Device: 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16512220
• MDR Text Key: 311529205
• Report Number: 3002809144-2023-00112
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06C37-27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, 116UNKNOWN11.; ARC I2000SR INST, 03M74-02, 116UNKNOWN11.; ARC I2000SR INST, 03M74-02, 116UNKNOWN11.
• Patient Age: 22 YR
• Patient Sex: Male