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

Catalog Number 710-100

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

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.B3: the date provided is an approximation as the exact event date was not provided the required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, complaints against these trend codes are monitored to identify and track any out-of-trend / unexpected performance at the lot and product family level.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.H3 other text : single use; device discarded.

Event Description

The customer reported an unspecified number of false results with the binaxnow streptococcus pneumoniae antigen card performed on an unknown date on an unknown sample type.No additional test information, including if the patient results were false positive or negative results, was provided.No additional patient information, including treatment and outcome, was provided.

• 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: 18678381
• MDR Text Key: 335412696
• Report Number: 1221359-2024-00163
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• 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