MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW STREP PNEUMONIAE 22T (LFR); ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.

Catalog Number 710-100

Device Problem Non Reproducible Results (4029)

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

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

D4 udi: (b)(4).Date of event provided in section b3 is an approximation, was not provided by consumer.This report is being filed on an international product, list number 710-100 that has a similar product distributed in the us, list number 710-000.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 conflicting results with the binaxnow strep pneumoniae performed on an unknown date on an unknown sample type.The customer reported that the digival was reading the card as positive while a person would visually read the card as negative.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

D4 udi: (b)(4).This report is being filed on an international product, list number 710-100 that has a similar product distributed in the us, list number 710-000.The investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.

Event Description

The customer reported conflicting results with the binaxnow strep pneumoniae performed on (b)(6) 2024 on a urine sample.The customer reported that the digival was reading the card as positive while a person would visually read the card as negative.Repeat testing was performed which generated a negative result.The customer stated the patient was symptomatic.The customer confirmed there was no impact in the patient's treatment.

Event Description

The customer reported conflicting results with the binaxnow strep pneumoniae performed on (b)(6)2024 on a kitted urine swab sample.The customer reported that the digival was reading the card as positive while a person would visually read the card as negative.Repeat testing was performed which generated a negative result.The customer stated the patient was symptomatic.The customer confirmed there was no impact in the patient's treatment.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

Additional information: b3, b5, b7 d4 udi: (b)(4) this report is being filed on an international product, list number 710-100 that has a similar product distributed in the us, list number 710-000.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 conflicting results with the binaxnow strep pneumoniae performed on (b)(6) 2024 on a urine sample.The customer reported that the digival was reading the card as positive while a person would visually read the card as negative.Repeat testing was performed which generated a negative result.The customer stated the patient was symptomatic.The customer confirmed there was no impact in the patient's treatment.

Manufacturer Narrative

D4 udi: (b)(4).This report is being filed on an international product, list number 710-100 that has a similar product distributed in the us, list number 710-000.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 236027w with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 710-100 / lot 236027w, test base part number 710-430r/ lot 234429.The lot met the required release specifications.A review of the complaints reported as false positive and false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 236027w showed that the complaint rate is (b)(4) respectively.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.

• Brand Name: BINAXNOW STREP PNEUMONIAE 22T (LFR)
• Type of Device: ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
• 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: 18741246
• MDR Text Key: 335815219
• Report Number: 1221359-2024-00208
• Device Sequence Number: 1
• Product Code: GTZ
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/16/2024

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: Health Professional
• Device Catalogue Number: 710-100
• Device Lot Number: 236027W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 02/23/2024; 03/31/2024; 05/08/2024
• Supplement Dates FDA Received: 03/12/2024; 04/03/2024; 05/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2023
• 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