MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-25 for QUICKVUE DIPSTICK STREP A TEST 20108 manufactured by Quidel Corp..
[21165292]
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.
Patient Sequence No: 1, Text Type: N, H10
[21244474]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024674-2014-00001 |
| MDR Report Key | 3987583 |
| Report Source | 06 |
| Date Received | 2014-07-25 |
| Date of Report | 2014-07-25 |
| Date of Event | 2014-02-12 |
| Date Mfgr Received | 2014-06-25 |
| Date Added to Maude | 2014-08-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JENNIFER RIAL |
| Manufacturer Street | 12544 HIGH BLUFF DR STE 200 |
| Manufacturer City | SAN DIEGO CA 92130 |
| Manufacturer Country | US |
| Manufacturer Postal | 92130 |
| Manufacturer Phone | 8585527910 |
| Manufacturer Street | 10165 MCKELLAR CT. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUICKVUE DIPSTICK STREP A TEST |
| Generic Name | RAPID STREP A TEST |
| Product Code | GTY |
| Date Received | 2014-07-25 |
| Model Number | NA |
| Catalog Number | 20108 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUIDEL CORP. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-25 |