MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ABBOTT REALTIME IDH1 ASSAY; ISOCITRATE DEHYDROGENASE 1 (IDH1) GENE MUTATION IVD, KIT, NUCLEIC ACID TECHNIQUE

Catalog Number 08N90-90

Device Problem False Negative Result (1225)

Patient Problem Insufficient Information (4580)

Event Date 08/18/2022

Event Type  Injury  

Manufacturer Narrative

Elevated complaint investigation will be initiated.

Event Description

The customer reported one false negative result on the abbott realtime idh1 assay.The customer reported a discrepant result for the r132h mutation while using the abbott realtime idh1 assay.Sample id (sid) (b)(6) was tested on (b)(6) 2022, and the result was "not detected" for the r132h mutation.The negative result was reported to the patient's physician.The physician contacted the customer's laboratory to let them know that the patient's sample was re-tested at a different laboratory and the result was "detected: for the r132h mutation.It is not known why the physician questioned the result and had another test performed at a different laboratory.The sample was then retested using three different samples in the customer's laboratory on (b)(6) 2022.The three samples were the original extracted material, freshly extracted material from the original patient sample vial (sid (b)(6)), and material provided by the outside laboratory (sid (b)(6)).All three samples (from the same patient) had mutation r132h detected.The effect on the patient's health management is not known.A medical opinion was obtained for the potential delay in treatment for > 5 days and concluded in a worst-case scenario, this event meets the definition of a serious injury.

Manufacturer Narrative

Investigation into this complaint included a customer data review, retain / file sample evaluation, a quality data review and a complaint history review.Investigation is summarized as follows: customer data review the customer is utilizing qiacube as dna extraction method.This method has been validated by the laboratory, however, is off-label, according to the abbott realtime idh1 package insert ((b)(6)), where a manual extraction method with the dna extraction kit part number (pn) 06k12-24 is the abbott molecular validated sample processing method.The customer result log files were reviewed.The runs which involved the discrepant results were valid and met assay specification requirements.The validity of the runs met assay specification requirements, and no error codes or flags were displayed for the run controls.This review found that the sample on the first run indicated a low pcr efficiency, which can be due to a variety of factors, including reagents, instrument performance or human error during preparation of the sample.There was likely an error with one of the previously listed factors that contribute to pcr efficiency.The results suggest instrument and reagents performed as expected for controls and the issue was likely associated with sample on non-detect run.There is no indication that the abbott realtime idh1 amplification kit (list 08n90-90) lot 526956 is performing outside of established design performance specifications based on the elements reviewed in this section.Retain / file sample evaluation: testing of the technical product support file samples showed that abbott realtime idh1 amplification kit (list 08n90-90) lot 526956 continues to meet all validity and acceptance criteria of the established design performance specifications.Quality data review device history record / batch record review: the device history records (dhr) review for abbott realtime idh1 amplification kit (list 08n90-90) lot 526956 (including the components) was performed.The manufacturing packets were reviewed to identify any issues related to the reported complaint during production of the lot components.No issues were identified.No issues were found during quality control (qc) testing.The products passed quality specifications at the time of release.Supporting information review: a quality data review was performed for the abbott realtime idh1 package insert ((b)(6)).A "not detected" result does not preclude the presence of idh1 mutations in the specimen.Assay results may be affected by inadequate specimen integrity, mutation content in the sample, and amount of amplifiable dna.(limitations of the assay, page 8).Use of the abbott realtime idh1 assay is limited to personnel who have been trained in the procedures of molecular diagnostic assays, the abbott m2000rt instrument, and the manual sample preparation method for abbott realtime idh1.(limitations of the assay, page 8).Capa / non-conformance review: the capa review for abbott realtime idh1 amplification kit (list 08n90-90) lot 526956 (including the components) was performed to identify any records that were potentially related to the reported complaint.The search did not identify any records related to the reported issue for these lot numbers.Complaint history review a lot specific complaint history review was performed to identify any similar complaints to the ticket being investigated, which reported discrepant results while using abbott realtime idh1 amplification kit (list 08n90-90) lot 526956.A product deficiency was not identified by this evaluation.Based on the results of the investigation elements, a product deficiency for abbott realtime idh1 amplification kit (list 08n90-90) lot 526956 was not identified.

• Brand Name: ABBOTT REALTIME IDH1 ASSAY
• Type of Device: ISOCITRATE DEHYDROGENASE 1 (IDH1) GENE MUTATION IVD, KIT, NUCLEIC ACID TECHNIQUE
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60018-3315 ; 2242064064
• MDR Report Key: 15392990
• MDR Text Key: 299604530
• Report Number: 3005248192-2022-00793
• Device Sequence Number: 1
• Product Code: OWD
• UDI-Device Identifier: 00884999047358
• UDI-Public: 0884999047358
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 06/03/2023
• Device Catalogue Number: 08N90-90
• Device Lot Number: 526956
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/09/2022
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other