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U.S. Department of Health and Human Services

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

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QUIDEL CORP. QUICKVUE DIPSTICK STREP A TEST; RAPID STREP A TEST Back to Search Results
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.
 
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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 Key3987583
MDR Text Key21165292
Report Number2024674-2014-00001
Device Sequence Number1
Product Code GTY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011097
Number of Events Reported1
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 Number20108
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/25/2014
Initial Date FDA Received07/25/2014
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 Number1
Patient Outcome(s) Required Intervention;
Patient Age4 YR
Patient Weight21
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