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

Catalog Number 02G28-91

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

Complaint investigation will be performed.Note: lot, expiration, udi, manufacture date and pma/510k number have been left blank as this mdr is being submitted on the basis that abbott realtime ct/ng amplification reagent kit (2g28-91) is similar to the abbott realtime ct/ng amplification reagent kit (8l07-91) sold in the united states.Ticket does not reference a us list 8l07-91 lot number.

Event Description

The customer reported one sample on the realtime ct/ng assay run had a "positive" result for ng with dc (delta cycle) 0.00.Customer verified there was a slight raise in the amplification curve at cycle 45.The molecular application specialist (mas) reviewed result files of the run in question.The specimen in question had a cycle number of 40.28, which was matching the cycle number of the cut-off controls, 40.28, resulting in dc 0.00.As per the package insert the sample should have been reported positive for ng.Per abbott realtime ct/ng package insert (51-608362/r3) "ng samples with a cycle number less than or equal to the assay co are interpreted as "positive".The specimen was re-tested from the same sample vial.The repeated result was negative.The medical director of the lab deemed the specimen result inconclusive and requested re-draw.New sample was requested for repeat testing.There have been no report of impact to the patient.Follow up with the customer indicated that this patient was not ordered to be tested for ng, therefore there was no previous medical history available.Customer stated that since there was a possibility of infection and therefore public health concern, he relayed the suspicious result to the patient's physician.The physician was very appreciative of the warning.Patient may or may not have been re-tested.Although it is unknown if the sample was truly positive as the results of the requested repeat testing with a new sample are unavailable, this evaluation will be processed as a false negative result as the customer relayed the suspicious result to the patient's physician.This incident is being reported to fda because the incident occurred in (b)(6) using realtime ct/ng list number 2g28-91 which is same/similar to us fda approved realtime ct/ng list number 8l07-91.

Event Description

The customer reported one sample on the realtime ct/ng assay run had a "positive" result for ng with dc (delta cycle) 0.00.Customer verified there was a slight raise in the amplification curve at cycle 45.The molecular application specialist (mas) reviewed result files of the run in question.The specimen in question had a cycle number of 40.28, which was matching the cycle number of the cut-off controls, 40.28, resulting in dc 0.00.As per the package insert the sample should have been reported positive for ng.Per abbott realtime ct/ng package insert (51-608203/r4) "ng samples with a cycle number (cn) less than or equal to the cutoff decision cycle (co) are interpreted as "positive"." the specimen was re-tested from the same sample vial.The repeated result was negative.The medical director of the lab deemed the specimen result inconclusive and requested re-draw.New sample was requested for repeat testing.There have been no report of impact to the patient.Follow up with the customer indicated that this patient was not ordered to be tested for ng, therefore there was no previous medical history available.Customer stated that since there was a possibility of infection and therefore public health concern, he relayed the suspicious result to the patient's physician.The physician was very appreciative of the warning.Patient may or may not have been re-tested.Although it is unknown if the sample was truly positive as the results of the requested repeat testing with a new sample are unavailable, this evaluation will be processed as a false negative result as the customer relayed the suspicious result to the patient's physician.This incident is being reported to fda because the incident occurred in canada using realtime ct/ng list number 2g28-91 which is same/similar to us fda approved realtime ct/ng list number 8l07-91.

Manufacturer Narrative

Updated october 10, 2019: was updated from "per abbott realtime ct/ng package insert (51-608362/r3) "ng samples with a cycle number less than or equal to the assay co are interpreted as "positive."" to "per abbott realtime ct/ng package insert (51-608203/r4) "ng samples with a cycle number (cn) less than or equal to the cutoff decision cycle (co) are interpreted as "positive"." to correctly reflect the package insert number and package insert guidance.

Manufacturer Narrative

Investigation into this complaint included an existing data review, a quality data review, and a complaint history review.The results of the investigation are summarized as follows: existing data review: the abbott realtime ct/ng package insert (51-608203/r3) was reviewed.This labeling review concluded that the related labeling is sufficient to address the reported complaint.Customer data review: the original run was 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 02g28-91) lot 496037 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 02g28-91) lot 496037 and its components was performed.The review did not identify any issues which could result in the reported complaint during the production or the release testing for lot 496037.The corrective and preventative action (capa) review for abbott realtime ct/ng amplification kit (list 02g28-91) lot 496037 and its components was performed 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 ct/ng amplification kit (list 02g28-91) lot 496037 identified one additional complaint ticket related to this issue.This ticket was investigated independently and no product deficiency was identified.Based on the results of the investigation elements, a product deficiency for the abbott realtime ct/ng amplification kit (list 02g28-91) lot 496037 was not identified.

• Brand Name: ABBOTT REALTIME CT/NG II AMPLIFICATION REAGENT KIT
• Type of Device: DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• MDR Report Key: 9173421
• MDR Text Key: 191918212
• Report Number: 3005248192-2019-00007
• Device Sequence Number: 1
• Product Code: MKZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 02G28-91
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1