MAUDE Adverse Event Report: DAKO NORTH AMERICA, INC ARTISAN ACID-FAST BACILLUS (AFB) STAIN KIT

Model Number AR162

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2020

Event Type  malfunction  

Event Description

Summary: based on complaint report or investigated failure mode, there was a staining alteration in staining.Customer complaint record reported the event as follows: pale staining.No direct or indirect patient harm or user harm have been reported.

• Brand Name: ARTISAN ACID-FAST BACILLUS (AFB) STAIN KIT
• Type of Device: ARTISAN ACID-FAST BACILLUS (AFB) STAIN KIT
• Manufacturer (Section D): DAKO NORTH AMERICA, INC; 6392 via real; carpinteria, ca, ca
• Manufacturer (Section G): DAKO DENMARK APS; produktionsvej 42; glostrup, 2600 ; DA 2600
• Manufacturer Contact: thiago lima ; produktionsvej 42; glostrup, 2600 ; DA 2600
• MDR Report Key: 10453306
• MDR Text Key: 206862259
• Report Number: 2022180-2020-00301
• Device Sequence Number: 1
• Product Code: ICL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR162
• Device Catalogue Number: AR16211-2
• Device Lot Number: 11161695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1