MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ABBOTT REALTIME IDH1 AMPLIFICATION REAGENT KIT; SOMATIC GENE MUTATION DETECTION SYSTEM

Model Number 08N90-090

Device Problem Non Reproducible Results (4029)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Complaint investigation will be performed.

Event Description

Customer alleges discrepant results when running the realtime idh1 assay.Customer originally tested patient sample id dl-19-82019 on (b)(6) 2019 with result r132c detected (near the threshold cycle).Patient sample was reported as r132c.On (b)(6) 2019, customer tested sample patient extraction as part of internal validation and it generated a resulted of not detected (this time result for r132g was near the threshold cycle).Customer continued to test the sample as results were erratic.Four additional retests were performed, which resulted in 3 not detected results and one result of r132g detected.Customer confirmed that the reporting results are associated with patient management.Customer is running whole blood samples.Controls were within range; global service and support, research and development and technical product specialist have reviewed the log files.Per the customer, eluates were stored properly according the idh1 package insert.There has not been an allegation of adverse impact to patient management.The customer stated that he had a follow up conversation with the treating physician.The treating physician has both mutations (r132c and r132g) as part of the patient's record.The physician said that the treatment protocol does not change based on the patient having either only one or both mutations.The treating physician did confirm that two different sample types had been sent in for the original testing and the repeat testing.One sample type was bone marrow and the other sample type was blood.

Manufacturer Narrative

On january 22, 2020 lot number information was made available.Therefore, follow up report includes lot number, expiration date and manufacture date.Investigation into this complaint was completed february 14, 2020.Investigation included a customer data review, a quality data review, and a complaint history review.The results of the investigation are summarized as follows: customer data review: results logs attached to the complaint were reviewed.All runs were valid, met all assay specification requirements, and no error codes or flags were displayed for the controls.There is no indication that the abbott realtime idh1 amplification kit (list 08n90-90) lot 498208 is performing outside of established design performance specifications.Quality data review: device history record (dhr) review for abbott realtime idh1 amplification kit (list 08n90-90) lot 498208 and components was performed.The review did not identify any issues which could result in the reported complaint.The products passed quality specifications at the time of release.The capa review was performed for abbott realtime idh1 amplification kit (list 08n90-90) lot 498208 and components and did not identify any internal or post-production use issues related to these lot numbers.Complaint history review: the lot specific complaint history review for abbott realtime idh1 amplification kit (list 08n90-90) lot 498208 did not identify any additional complaints related to the reported issue.Based on the results of the investigation elements, a product deficiency for the abbott realtime idh1 amplification kit (list 08n90-90) lot 498208 was not identified.

• Brand Name: ABBOTT REALTIME IDH1 AMPLIFICATION REAGENT KIT
• Type of Device: SOMATIC GENE MUTATION DETECTION SYSTEM
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• MDR Report Key: 9613389
• MDR Text Key: 191918319
• Report Number: 3005248192-2020-00001
• Device Sequence Number: 1
• Product Code: OWD
• UDI-Device Identifier: 00884999047358
• UDI-Public: 00884999047358
• Combination Product (y/n): N
• PMA/PMN Number: P170041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2020
• Device Model Number: 08N90-090
• Device Catalogue Number: 08N90-090
• Device Lot Number: 498208
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 01/21/2020
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1