MAUDE Adverse Event Report: ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST; ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP

Lot Number COV2010013

Device Problem Unclear Information (4052)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2023

Event Type  malfunction  

Manufacturer Narrative

The current complaint is pending investigation from our contract manufacturer, and we will provide follow up mdr upon investigation completion such as review of batch records or testing of retention samples.Any additional information received by acon may be provided to fda in a follow up mdr.

Event Description

Invalid result (s) and expiration issue.The customer is a former fda employee who emailed the fda to provide the following complaint: i find myself bringing this issue to your attention as a former cdrh opeq staff member who was assigned to the allegation team prior to retirement two years ago.Putting aside for the moment, the fact that it appears that home covid-19 tests are still being regulated by cdrh under an eua, rather than having been fully cleared, this long after the advent of the pandemic, i would like to express my dissatisfaction with the state of affairs described in detail below: product: flowflex covid-19 antigen home test.Manufacturer: acon laboratories, inc., san diego, ca 92121.Ref: l031-118b5.Lot: cov2010013.Labeled expiration date: 2023-01-06.Udi: (b)(4).Narrative: i purchased two of these products at a local kroger pharmacy on this date, (b)(6) 2023.On returning home with the products, i noticed that the labeled expiration date was "2023-01-06".Not wishing to use expired product, which may have been in store stock for too long, i returned to the kroger pharmacy and requested a refund.I was refused a refund of the unopened products by the store and told that the pharmacy had just received these products and had been informed that the expiration date for the products had been extended.I explained that i was not comfortable using a product with a labeled expiration date which had passed.The pharmacy then informed me that if i would scan the qr code on the package, it would take me to a web site which would explain that the expiration date had been extended.And, in fact, scanning the qr code led me to a web site which, part way down the page, included the following: "expiration date extension: as of march 15, 2023, the expiration date of the flowflex covid-19 antigen home test has been extended by 12 months.Please to check the new expiration date using the lot number printed on the test kit box." following the link led to an explanatory lookup table which showed that the specific lot number referenced above had an expiration date advanced to january 2024.Allegation and comments: i do not believe it is reasonable for the fda to permit this manufacturer (and perhaps others) to inform consumers who may purchase the products of the expiration date via this form of "labeling".While i am an educated health care product consumer, by virtue of my background, it may even be considered discriminatory to expect that every purchaser possesses a smartphone and sufficient understanding of how to scan qr codes in order to be able to assess the labeling and determine if the product is safe for use.With the knowledge that cdrh is concerned (arguably to a fault) with reducing the regulatory "burden" on manufacturers, i believe that the described labeling "workaround" increases the burden on the health care consumer (patient) particularly those who may be elderly or lack the knowledge or finances to be scanning qr codes on labels with smartphones.I would suggest that the burden in properly labeling these products should fall on the manufacturer, possibly in partnership with distributors.Returning to the aforementioned continued eua status of these products, this late in the game, i cannot help but believe that better oversight of the products by appropriate clearance or approval would examine such issues and avoid the situation described here (not to mention the requisite safety and effectiveness examination).I continue to hope that fda/cdrh has learned from all of our experiences during the pandemic and will apply this knowledge and experience going forward in regulating such products.It is my hope that all of the products granted authorization under an eua will be appropriately cleared or approved in reasonably short order, and not somehow grandfathered into the marketplace.Note that acon laboratories inc.Is being cc'd on this allegation using the email address provided in a recent (march 11, 2022) recall associated with the flowflex product.

Manufacturer Narrative

The current no abnormal issue was found in the manufacturing process, technical testing and quality control inspection, and the manufacturing process is complied with the dmr.Findings and summary: a label was attached on the outside kit box, which says "discharge expiration date on the inside pouch".Therefore, the expiration date on the inside pouch shall be discharged.In addition, the package insert ((b)(4)) of the product has already been revised as "do not use the test after the expiration date shown on the test cassette pouch.For more information on expiration dating for covid-19 antigen tests, please refer to http://www.Fda.Gov/covid-tests" in the section of warnings, precautions, and safety information on march 15, 2023 through a change (cor# co2302027).See the screenshot from the website linked in the package insert below, which tells that the shelf life for the product has been extended to 24 months.(picture attached) besides, a list of updated expirations dates was provided (see attachment i for details).To sum up, the current package insert do has clarified the information related to the product expiration date.In this follow-up report, the following information has been updated from the initial report upon completion of the internal investigation.

Event Description

Invalid result (s) and expiration issue.The customer is a former fda employee who emailed the fda to provide the following complaint: i find myself bringing this issue to your attention as a former cdrh opeq staff member who was assigned to the allegation team prior to retirement two years ago.Putting aside for the moment, the fact that it appears that home covid-19 tests are still being regulated by cdrh under an eua, rather than having been fully cleared, this long after the advent of the pandemic, i would like to express my dissatisfaction with the state of affairs described in detail below: product: flowflex covid-19 antigen home test.Manufacturer: acon laboratories, inc., san diego, ca 92121.Ref: l031-118b5.Lot: cov2010013.Labeled expiration date: 2023-01-06.Udi: (b)(4).Narrative: i purchased two of these products at a local kroger pharmacy on this date, 8/21/2023.On returning home with the products, i noticed that the labeled expiration date was "2023-01-06".Not wishing to use expired product, which may have been in store stock for too long, i returned to the kroger pharmacy and requested a refund.I was refused a refund of the unopened products by the store and told that the pharmacy had just received these products and had been informed that the expiration date for the products had been extended.I explained that i was not comfortable using a product with a labeled expiration date which had passed.The pharmacy then informed me that if i would scan the qr code on the package, it would take me to a web site which would explain that the expiration date had been extended.And, in fact, scanning the qr code led me to a web site which, part way down the page, included the following: "expiration date extension: as of march 15, 2023, the expiration date of the flowflex covid-19 antigen home test has been extended by 12 months.Please to check the new expiration date using the lot number printed on the test kit box." following the link led to an explanatory lookup table which showed that the specific lot number referenced above had an expiration date advanced to january 2024.Allegation and comments: i do not believe it is reasonable for the fda to permit this manufacturer (and perhaps others) to inform consumers who may purchase the products of the expiration date via this form of "labeling".While i am an educated health care product consumer, by virtue of my background, it may even be considered discriminatory to expect that every purchaser possesses a smartphone and sufficient understanding of how to scan qr codes in order to be able to assess the labeling and determine if the product is safe for use.With the knowledge that cdrh is concerned (arguably to a fault) with reducing the regulatory "burden" on manufacturers, i believe that the described labeling "workaround" increases the burden on the health care consumer (patient) particularly those who may be elderly or lack the knowledge or finances to be scanning qr codes on labels with smartphones.I would suggest that the burden in properly labeling these products should fall on the manufacturer, possibly in partnership with distributors.Returning to the aforementioned continued eua status of these products, this late in the game, i cannot help but believe that better oversight of the products by appropriate clearance or approval would examine such issues and avoid the situation described here (not to mention the requisite safety and effectiveness examination).I continue to hope that fda/cdrh has learned from all of our experiences during the pandemic and will apply this knowledge and experience going forward in regulating such products.It is my hope that all of the products granted authorization under an eua will be appropriately cleared or approved in reasonably short order, and not somehow grandfathered into the marketplace.Note that acom laboratories inc.Is being cc'd on this allegation using the email address provided in a recent (march 11,2022) recall associated with the flowflex product.

• Brand Name: FLOWFLEX COVID-19 ANTIGEN HOME TEST
• Type of Device: ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP
• Manufacturer (Section D): ACON LABORATORIES, INC.; 5850 oberlin drive #340; san diego CA 92121
• Manufacturer (Section G): ACON LABORATORIES, INC.; 5850 oberlin drive #340; san diego CA 92121
• Manufacturer Contact: qiyi xie
• MDR Report Key: 17704626
• MDR Text Key: 322938851
• Report Number: 2531491-2023-00642
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• PMA/PMN Number: EUA210494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/06/2023
• Device Lot Number: COV2010013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 08/22/2023
• Supplement Dates FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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