MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW INFLUENZA A/B 2.0 (24T); INFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAY; REAL TIME NUCLEIC ACID

Catalog Number 427-000

Device Problem False Positive Result (1227)

Patient Problems Cardiac Arrest (1762); Insufficient Information (4580)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

The customer reported a false positive result with the id now influenza a/b assay performed on an unknown date.The customer reported that the patient was sent home and after few days had a cardiac arrest at home and died.The postmortem report confirmed that the patient was not flu b positive.Although requested, no additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

Abbott medical affairs determination indicated that while there is no clear reason to explain why a false positive flu b result could cause a sudden cardiac arrest, the evidence is lacking to make a definitive conclusion and therefore should be reported as such.Date of death and date of event provided in section b2 and b3 is an approximation, was not provided by consumer.The investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.H3 other text : single-use, device discarded.

Event Description

The customer reported a false positive result with the id now influenza a/b assay performed on (b)(6)2024 on a nasal sample.Confirmation pcr testing was performed which generated an unknown result.The customer reported that the patient was sent home and after few days had a cardiac arrest at home and died.The postmortem report confirmed that the patient was not flu b positive.The customer reported that the patient was visited by ed and there was subsequent admittance to the hospital.There is no evidence of myocarditis on the postmortem evaluation.Additionally, there is no evidence of severe pneumonia or other infectious lung damage on the postmortem evaluation.The customer confirmed on (b)(6)2024 that there is no documented account of a false flu b positive result causing or contributing to the death of any patient.Although requested, the customer stated that no further information will be provided.

Manufacturer Narrative

D4 udi: (b)(4) additional information provided by the customer indicated that there was no death of a patient attributed to a false positive flu b result.See below for sections with updated information.B1 - adverse event/product problem b2 - date of death b2 - death date null b2 - outcomes attributed to ae b2 - outcomes attributed to ae null b5 d4 - lot # d4 - expiration date e1 - phone number e1 - email h1 - type of reportable event h4 - device mfg date h6 - health effect - clinical code h6 - health effect - impact code response to fda request for additional information which was sent directly to the fda lead reviewer contact on 08mar2024: abbott diagnostics scarborough, inc.Registration number 1221359, received your email dated march 05, 2024 requesting additional information related to mdr #1221359-2024-00233, which included a report of a patient death and an alleged false positive result with the id now influenza a/b 2.0 (24t) assay.Abbott submitted the mdr as both a death and product problem report (malfunction) because the cause of death was unknown.The initial report received was that a patient death occurred; however, the cause was unknown.At the time of the initial report, the patient died after testing false positive for flu b but there was no suspected or confirmed relationship between the death and the use of the id now product.To date, we have made four attempts to retrieve additional information.However, university hospital limerick (uhl) is currently experiencing a surge in capacity and therefore response times may be delayed.The following is a summary of the information we were able to obtain: 1.Is a patient medical history available? beyond the information below, no additional patient information has been made available.2.Is a medical examiner¿s report available? the customer has communicated that they do not have access to the medical examiner¿s report.3.How much time elapsed between the positive flu b result and the patient¿s death? the initial report provided to abbott indicated the patient experienced cardiac arrest a few days after the false positive flu b test result.The specific time elapsed has been requested, however the customer is requesting clarification of hospital policies regarding general data protection regulation (gdpr) before providing any further details.4.What method was used to determine the patient was negative for flu b at the time of death? a pcr test was used by the limerick serology department to determine the patient was negative for flu b at the time of death.We have not confirmed the time of collection of the pcr sample.5.Was the id now device the patient used available for examination by your firm? the id now influenza a&b test reagent (lot m239443) is a single-use assay and is therefore not available for return from the customer.We are in the process of obtaining the instrument for investigation.Instrument log files have been received.Please see below for investigation summary in # 9.6.Did the patient seek medical attention during this illness at all? other than the patient¿s admission to the university hospital limerick emergency department where the flu b test was performed, we have not obtained information regarding any other medical attention received by the patient.7.Is there any evidence of myocarditis on the postmortem evaluation? we have provided this request to the customer and are awaiting a response.8.Is there any evidence of severe pneumonia or other infectious lung damage on the postmortem evaluation? we have provided this request to the customer and are awaiting a response.9.Please include a summary of your investigation the batch history record review (bhr) for idnow influenza a/b kit part number 427-000 / lot m239443 and test base part number 427-430 / lot m239443 revealed that the product met acceptance criteria for release.The id now influenza a&b 2 retain kit lot m239443 was tested with the abbott diagnostics scarborough¿s limit of detection (lod) positive controls for flu a, flu b, universal transport medium (utm), and elution buffer.All tests were run in duplicate, were valid, and performed as expected.No false positive results were observed, and the customer complaint was not replicated.The current overall incident rate for false positive (confirmed, unconfirmed, conflicting) patient results for lot m239443 based on the total quantity of devices distributed is (b)(4).Based on the evidence available to date, the lot is performing as expected.We are in the process of obtaining the instrument for investigation.The logfiles for the instrument (serial number 342c411d) were obtained from the customer and reviewed for an id now influenza b false result with lot m239443 for the date and time provided.The initial review has confirmed that a valid influenza b positive result was produced at the date and time specified and there were no obvious run errors or instrument performance issues observed during this same time period.However, a detailed analysis of the instrument logfiles is ongoing.To date we have not identified a product deficiency.A supplemental mdr will be submitted upon completion of the investigation and will include the final investigation findings.H3 other text : single-use, device discarded.

Event Description

The customer reported a false positive result with the id now influenza a/b assay performed on 08feb2024 on a nasal sample.Confirmation pcr testing was performed which generated an unknown result.The customer reported that the patient was sent home and after few days had a cardiac arrest at home and died.The postmortem report confirmed that the patient was not flu b positive.The customer reported that the patient was visited by ed and there was subsequent admittance to the hospital.There is no evidence of myocarditis on the postmortem evaluation.Additionally, there is no evidence of severe pneumonia or other infectious lung damage on the postmortem evaluation.The customer confirmed on 12mar2024 that there is no documented account of a false flu b positive result causing or contributing to the death of any patient.Although requested, the customer stated that no further information will be provided.

Manufacturer Narrative

D4 udi: (b)(4).Additional information as instrument was returned for investigation: d9 - device available for evaluation, d9 - date returned to mfg , h2 - if follow-up, what type? , h3 - device evaluated by mfg, h6 (type of investigation), h11.Instrument investigation summary: the instrument sn (b)(4) was returned for further investigation.The logfile was reviewed for an id now influenza b false positive result with lot m239443.The following was noted: valid influenza b positive results with no errors or issues observed.During evaluation of the instrument, ten (10) sequential tests with covid-19 and flu a/b assay were run with negative controls.All results were negative.No false positive results were observed.The customer complaint was not replicated.Instrument media files were reviewed for any errors and anomalies occurring during the 10 flu/covid sequential workflow trials.All tests completed normally with no errors or anomalies recorded.Based on the results the instrument appears to be operating as expected.In conclusion, abbott diagnostics scarborough did not identify a product deficiency.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue, however it could have been related to the specific patient sample.Substances in the sample itself may have interfered with the reaction.Based on the above summary, the investigation is deemed complete.Abbott diagnostics scarborough will continue to monitor and trend for this reported issue as part of our ongoing post market surveillance.

• Brand Name: ID NOW INFLUENZA A/B 2.0 (24T)
• Type of Device: INFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAY; REAL TIME NUCLEIC ACID
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 18817858
• MDR Text Key: 336677626
• Report Number: 1221359-2024-00233
• Device Sequence Number: 1
• Product Code: OZE
• UDI-Device Identifier: 10811877010422
• UDI-Public: 10811877010422
• Combination Product (y/n): N
• Reporter Country Code: IE
• PMA/PMN Number: K171792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 427-000
• Device Lot Number: M239443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 26 YR
• Patient Sex: Male