MAUDE Adverse Event Report: GEN-PROBE INCORPORATED ACCUPROBE GROUP B STREP TEST

Catalog Number 2820B

Device Problems Improper or Incorrect Procedure or Method (2017); Incorrect Or Inadequate Test Results (2456)

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

Event Date 01/07/2014

Event Type  No Answer Provided  

Event Description

The technician at (b)(6) reported testing with the kit, bulk, group b strep, accuprobe (mn: (b)(4) bn: (b)(4)) and incorrectly used the reagents.Three samples which were originally negative were positive using the correct reagents.Although there was correction of the reported results, there existed the potential for false negative test results and the potential for delay in treatment of true positive test results.This not a device error or a failure with the product, but rather an operator error based on improper use of the reagent.

Manufacturer Narrative

Evaluation not required.User error.

• Brand Name: ACCUPROBE GROUP B STREP TEST
• Type of Device: GROUP B STREP
• Manufacturer (Section D): GEN-PROBE INCORPORATED; 10210 genetic center drive; san diego CA 92121 436
• Manufacturer (Section G): GEN-PROBE INCORPORATED; 10210 genetic center drive; san diego CA 92121 436
• Manufacturer Contact: joseph mcmullen ; 10210 genetic center drive; san diego, CA 92121-4362 ; 8584108897
• MDR Report Key: 3680237
• MDR Text Key: 4243482
• Report Number: 2024800-2014-00002
• Device Sequence Number: 1
• Product Code: MDK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 01/15/2014
• Device Catalogue Number: 2820B
• Device Lot Number: 633429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1