MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. VYSIS CLL FISH PROBE KIT; CHRONIC LYMPHOCYTIC LEUKEMIA FISH PROBE KIT

Model Number 04N02-021

Device Problem False Negative Result (1225)

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

Event Date 07/26/2021

Event Type  malfunction  

Event Description

Customer reported concern due to having tested patient samples with cll fish probe kit lot, 518656 and 517068.On july 27th, the customer expressed concern to their ambassador after reading a post published by (b)(6) university.Customer later received fa-am-aug2021-258a (ticket (b)(4)), which acknowledges that vysis cll fish probe kit, list 04n02-021 lots 517086 and 518656 have been linked to reports of the vysis cll fish probe kits not detecting 13q deletions in known positive patient samples.New lot of cll fish probe was shipped to customer and previously released negative patient samples are to be verified with the new lot.Ticket was marked as potential reportable event (pre) due to potential impact once patient samples are re-tested.At this time number of patient samples possibly affected is not known.Impact to patient management is not known.Customer follow up indicates that patient re-testing has not taken place due to shortage of reagent supply.Customer will be out of office week of aug 23rd.At this time, there is no allegation of discrepant results, however this evaluation will be processed as a worst case false negative result on cll probe, 4n02-21, which is associated with a moderate severity, as this was the potential impact addressed in fa-am-aug2021-258a.*note, abott awareness date of 8/2/2021 will be utilized as this is the date a decision was made to execute reportable field action fa-am-aug2021-258a.This complaint is reported in accordance with 21 cfr 803 on the basis that a reportable (21 cfr 806) field action, fa-am-aug2021-258a, was taken to address the issue.

Manufacturer Narrative

Review of this event indicates that it is associated with a confirmed issue in a previously conducted investigation.This event documents that cll probe (kit ln 04n02-21/lot 518656, probe bottle: part# 30-241050/lot 516558) exhibited unusual and unexpected 13q results.Investigation into this complaint included an evaluation of the quality data review (device history record (dhr) review and capa review) and complaint history review.The results of the investigation are summarized as follows: quality data review device history record / batch record review the following records were reviewed: a.Vysis lsi d13s319 so/13q34 sa/cep 12 sg probes, 200ul-ivd: manufacturing procedure mp-30-241050 rev.002/lot# 516558 (includes quality test data: quality procedure qp- 30-241050 rev.001/lot# 516558).B.Lsi d13s319 so/13q34 sa/cep 12 sg bulk formulation: mp-30-191124 rev.003/lot# 516056 (includes quality test data: quality procedure qp- 30-191124 rev.002/lot# 516056).No errors/issues were identified.The review verified that the products under investigation met quality specifications at the time of release.Capa / non-conformance review searched for related functional performance product and process exceptions in reference to vysis lsi d13s319 so/13q34 sa/cep 12 sg probes lot# 516558 in question, the bulk lot of material used to manufacture the probe lot in question (lot# 516056) and kits manufactured using the probe lot in question (kit lot# 517086, 518656, 517516 and 519303).Each lot is qualified at the probe/bottle lot and bulk lot manufacturing stage for the materials in question; therefore, the search was lot specific.All related material in question was accounted for in the search criteria.Any resulting capa were then reviewed to determine relevance to this investigation.No capa records identified related to customer's reported issue.Product/system/instrument evaluation: retain / file sample evaluation: retain sample vysis lsi d13s319 so/13q34 sa/cep 12 sg probes, 200ul-ivd: part# 30-241050/lot# 516558 was tested according to part-specific qp-30-241050 rev.001: vysis lsi d13s319 so/13q34 sa/cep 12 sg probes, 200ul-ivd in previous complaint investigation and met specifications.Complaint history review: searched for all complaints in reference to vysis lsi d13s319 so/13q34 sa/cep 12 sg probes lot# 516558 in question and kits manufactured using the probe lot in question (kit lot# 517086, 518656, 517516 and 519303).Each unique lot is qualified at the bulk and bottle probe manufacturing stage for the material in question; therefore, the search was lot specific.All related material in question was accounted for in the search criteria.Based on the results of the complaint history review a product deficiency has been identified.Specification not met: the complaint review identified a significant trend in unusual and unexpected results when using the bottled probe vysis lsi d13s319 so/13q34 sa/cep 12 sg probes, 200ul-ivd: part# 30-241050/lot# 516558.Five complaints were identified as a result of the search that are related to the same documented issue for these lots.Four of those complaints were addressed as the focus of the previously conducted investigation.These four complaints were opened in a short period of time, between 7/23/2021 and 7/27/2021.One additional complaint was addressed through a previous investigation which determined no deficiency identified at time of investigation.All are related to the failure to detect the 13q deletion in known positive samples.Per the vysis cll fish probe kit package insert, 30-608712/r4: the vysis cll fish probe kit is a test to detect deletion of the lsi tp53, lsi atm, and lsi d13s319 probe targets and gain of the d12z3 sequence probe target via fluorescence in situ hybridization (fish) in peripheral blood specimens from patients with b-cell chronic lymphocytic leukemia (cll).The trend in complaints has determined a product deficiency.Abbott molecular determined that a field corrective action (fa-am-aug2021-258a) should be taken and reported this issue per 21 cfr 806 to the fda on august 16, 2021 (report number 3005248192-08-01-2021-001-c).The field corrective action was in the form of a field correction recall letter / urgent field safety notice, dated august 4, 2021 instructing customers to discontinue use of and discard all remaining inventory of the lots listed in the letter.Also included in the letter were considerations for healthcare providers as guidance for retesting of potentially impacted patients.

Manufacturer Narrative

B5 updated with additional customer follow up.

Event Description

Additional follow up with customer on 9/15/2021, indicates that the customer has started repeat testing of previously tested patient samples; around 50-60 samples are involved.As of 9/15/2021, approximately half of the results have changed from negative to positive for the 13q deletion.Customer stated that it will take another couple of weeks to perform the remaining testing.Customer is unable to provide information regarding impact on patient care until all pertaining work is finished.Multiple attempts were made to gather additional information, but the customer did not respond.There has been no report of impact to patient management.

• Brand Name: VYSIS CLL FISH PROBE KIT
• Type of Device: CHRONIC LYMPHOCYTIC LEUKEMIA FISH PROBE KIT
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• MDR Report Key: 12375637
• MDR Text Key: 280478499
• Report Number: 3005248192-2021-00195
• Device Sequence Number: 1
• Product Code: OVQ
• UDI-Device Identifier: 00884999042780
• UDI-Public: 00884999042780
• Combination Product (y/n): N
• PMA/PMN Number: K100015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

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
• Device Operator: No Information
• Device Expiration Date: 04/19/2022
• Device Model Number: 04N02-021
• Device Catalogue Number: 04N02-21
• Device Lot Number: 518656
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1