MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCABOROUGH BINAXNOW COVID-19 HOME TEST; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number 195160

Device Problem Mechanical Problem (1384)

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

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.

Event Description

The user states that during testing the swab broke inside the patients nostril.The user stated that on the swab there was what looked like a marking and user thought it had to go all the way into the nostrils.The user then inhaled the broken swab.The swab was inside the user's sinus for 2 hours.The user went to the emergency room however sneezing ejected the swab out of the nose.Although attempts were made, no additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide a correction to the previously reported event.The lot number originally reported (138199) is the device lot for kit lot 144070.Further review of the case determined that the corresponding patient swab lots for outer kit lot 144070 are as follows: p0243, p0223, p0177.

Manufacturer Narrative

This supplemental report is being submitted to provide the investigation conclusion.Please see updates: inspections were performed at abbott diagnostics scarborough, inc.On retained kit lot 144070 for damaged patient swabs.All blank patients swabs under lots p0177, p0223, and p0243 were inspected.No damaged swabs were observed.Swabs were not scored and could only be broken after repeated bending back and forth.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 195-160 / lot: 144070.The lot met the required release specifications.The manufacturing batch records were also reviewed for component part number pk002545 / lots p0243, p0223, and p0177; the lots met the required release specifications.A review of the complaints reported as defective patient swabs related to kit lot 144070 showed that the complaint rate is (b)(4).The reported issue is anticipated in nature and severity for the binaxnow covid-19 antigen self-test according to risk documentation.No new hazard has been identified.In conclusion, abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue, however, it could be related to issues such as the self-test user performance.

Manufacturer Narrative

This supplemental report is being submitted to provide corrected data.Please see updates fields: d3, g4 & g1.

• Brand Name: BINAXNOW COVID-19 HOME TEST
• Type of Device: LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCABOROUGH; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 12444143
• MDR Text Key: 270528280
• Report Number: 1221359-2021-02480
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/07/2022
• Device Catalogue Number: 195160
• Device Lot Number: 138199
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 05/02/2022; 09/07/2022; 11/30/2022
• Supplement Dates FDA Received: 05/31/2022; 09/21/2022; 11/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2021
• 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): Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White