MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ABBOTT REALTIME CT/NG II AMPLIFICATION REAGENT KIT; DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA

Catalog Number	08L07-91
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation will be performed.
Event or Problem Description
The customer reported that one sample on the abbott ct/ng ii assay run had a "low-grade" positive result.The positive result was reported to the physician.The sample was re-tested, and the result was negative.The molecular application specialist (mas) reviewed the runs from abbottlink.The sample in question has good ic (internal control) amplification in both runs.The amplification curves and reference dye in the run looked as expected.The sample was a swab.In regards to the questioned results reported by the customer, the mas explained to the customer that due to nature of the specimen and behavior of the bacterial dna, the repeat test may not have picked up enough bacteria to have the ct detected.The customer will report the sample as "inconclusive", and they will request a repeat specimen.There was no impact on the patient's health due to the questioned results.Based on the mas review, this report is being processed as a false negative on the realtime ct/ng ii assay.
Additional Manufacturer Narrative
Investigation into this complaint 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: the runs were valid, met all assay specification requirements, and no error codes or flags were displayed for the cutoff controls or negative controls.There is no indication that the abbott realtime ct/ng amplification kit (list 08l07-91) lot 490156 is performing outside of established design performance specifications.Quality data review: the device history records (dhr) review for abbott realtime ct/ng amplification kit (list 08l07-91) lot 490156 and its components was performed.The review did not identify any issues which could result in the reported complaint.The capa review for abbott realtime ct/ng amplification kit (list 08l07-91) lot 490156 was performed and did not identify any internal or post-production use issues related to this lot or its components.Complaint history review: the lot specific complaint history review for abbott realtime ct/ng amplification kit (list 08l07-91) lot 490156 did not identify any additional complaint tickets.Product/system/instrument evaluation: product file sample testing was not performed as there is no indication that the abbott realtime ct/ng amplification kit (list 08l07-91) lot 490156 is performing outside of established design performance specifications.As stated in the customer data review section, the assay software and the abbott realtime ct/ng amplification kit (list 08l07-91) lot 490156 are performing as expected.The assay reagents performed as expected and met the assay specification requirements without any error codes or flags.Customer returns were not available.Based on the results of the investigation elements, a product deficiency for the abbott realtime ct/ng amplification kit (list 08l07-91) lot 490156 was not identified.

• Brand Name: ABBOTT REALTIME CT/NG II AMPLIFICATION REAGENT KIT
• Common Device Name: DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• MDR Report Key: 8262246
• Report Number: 3005248192-2019-00002
• Device Sequence Number: 13842134
• Product Code: MKZ
• UDI-Device Identifier: 00884999031142
• UDI-Public: 00884999031142
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K140354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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
• Operator of Device: No Information
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 08L07-91
• Device Lot Number: 490156
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1