MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT CMV IGG REAGENT KIT; ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Catalog Number 06C15-25

Device Problem False Negative Result (1225)

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

Event Date 07/11/2023

Event Type  malfunction  

Event Description

The following incidence describes a use error.The customer observed false nonreactive architect cmv igg results for multiple samples after a new reagent pack was started on (b)(6) 2023.Additionally, the positive quality control was out of range.The following data was provided: patient 1: initial result = 5.4 au/ml (nonreactive), repeat = 161.8 au/ml (reactive) (corrected report sent to physician); patient 2: initial result = 2.8 au/ml (nonreactive), repeat = 119.9 au/ml; patient 3: initial result = 1.6 au/ml (nonreactive), repeat = 63.7 au/ml; patient 4: initial result = 0.9 au/ml (nonreactive), repeat = 37.7 au/ml.The laboratory staff did not notice the drop in quality controls (controls out of range) before patients were tested and results were released from the lab.No impact to patient management was reported.

Manufacturer Narrative

Completed information for section a1 patient identifier: sids (b)(6), (b)(6), (b)(6), and (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation for false nonreactive architect cmv igm results included a search for similar complaints, trending data review, labeling review, device history records review, and in house testing.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review on lot 49574fn00 did not identify any nonconformances or deviations associated with the likely cause lot number and complaint issue.In-house specificity testing was completed using a retained sample of the complaint lot 49574fn00.All specifications were met and no false reactive results were obtained, indicating that the specificity performance is not impacted.Labeling was reviewed and found to adequately address the issue under review.Based on the information within the complaint record, use error caused the issue as the positive quality control was out of range.The laboratory staff did not notice the drop in quality controls (controls out of range) before patients were tested and results were released from the lab.Based on the investigation architect cmv igm reagent lot 49574fn00 is performing as intended, no systemic issue or deficiency of the architect cmv igm reagent was identified.

Event Description

The following incidence describes a use error.The customer observed false nonreactive architect cmv igg results for multiple samples after a new reagent pack was started on 11jul2023.Additionally, the positive quality control was out of range.The following data was provided: patient 1: initial result = 5.4 au/ml (nonreactive), repeat = 161.8 au/ml (reactive) (corrected report sent to physician).Patient 2: initial result = 2.8 au/ml (nonreactive), repeat = 119.9 au/ml.Patient 3: initial result = 1.6 au/ml (nonreactive), repeat = 63.7 au/ml.Patient 4: initial result = 0.9 au/ml (nonreactive), repeat = 37.7 au/ml.The laboratory staff did not notice the drop in quality controls (controls out of range) before patients were tested and results were released from the lab.No impact to patient management was reported.

• Brand Name: ARCHITECT CMV IGG REAGENT KIT
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17444405
• MDR Text Key: 320255842
• Report Number: 3008344661-2023-00140
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K220949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

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: 02/23/2024
• Device Catalogue Number: 06C15-25
• Device Lot Number: 49574FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2023
• 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, ISR51760; ARC I2000SR INST, 03M74-02, ISR51760