MAUDE Adverse Event Report: QUIDEL CORP. QUICKVUE DIPSTICK STREP A TEST; RAPID STREP A TEST

Catalog Number 20108

Device Problem False Positive Result (1227)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 02/12/2014

Event Type  Injury  

Manufacturer Narrative

The quickvue dipstick strep a test detects group a streptococcal antigen from throat swabs and is to be used to aid in the diagnosis of group a streptococcal infection.The test detects both viable and nonviable group a streptococci and may yield a positive result in the absence of living organisms.No used or unused devices, nor product lot numbers, were available to the mfr to aid in the investigation of the event.No complaint trend has been identified for the quickvue dipstick strep a test.

Event Description

A (b)(6) pt was treated for c.Difficile infection following several treatments of antibiotics based on (b)(6) test results with the quickvue dipstick strep a test.The pt has been evaluated and tested for group a strep at the facility on five occasions over a period of 5 months ((b)(6) 2013 to (b)(6) 2014).The pt was tested each time with the quickvue dipstick strep a test and, following (b)(6) test results, was treated with antibiotics for group a strep infection.During the last visit on (b)(6) 2014, the pt complained of belly pain.In addition to performing the quickvue assay, the facility performed a stool dna test for c.Difficile and sent a throat specimen for bacterial culture.The throat culture was negative.The stool test was (b)(6) for the detection of c.Difficile, and the pt received three rounds of antibiotic treatment on (b)(6)2014 (oral flagyl), (b)(6)2014 (oral vancomycin), and (b)(6) 2014 (oral vancomycin).The initial reporter indicated that she was not aware of any preexisting medical conditions and the pt had been otherwise healthy prior to (b)(6) 2014.The pt was negative for c.Difficile in (b)(6)2014 and there has been no recurrence.

• Brand Name: QUICKVUE DIPSTICK STREP A TEST
• Type of Device: RAPID STREP A TEST
• Manufacturer (Section D): QUIDEL CORP.; san diego CA
• Manufacturer Contact: jennifer rial ; 12544 high bluff dr; ste 200; san diego, CA 92130 ; 8585527910
• MDR Report Key: 3987583
• MDR Text Key: 21165292
• Report Number: 2024674-2014-00001
• Device Sequence Number: 1
• Product Code: GTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 20108
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 4 YR
• Patient Weight: 21