MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-11-07 for QUICKVUE DIPSTICK STREP A TEST KIT 20108 manufactured by Quidel Corp..
[16923840]
Mother of (b)(6) male reported the following events. The patient was brought to medical facility multiple times with symptoms of nausea and vomiting over a three-month period during (b)(6) 2011. Patient throat swabs were tested 6-7 times with the quickvue dipstick strep a test and received positive test results in each case. Patient was issued antibiotics after more than one visit (may include amoxicillin and clindamycin). Mother indicated that she believed the facility had performed back-up cell culture on more than one throat specimen taken from the patient, and the cultures were negative for group a streptococcus. However, she (as the parent) did not receive formal notification of these culture results from the facility. Patient was taken to an infectious disease doctor and ent doctor, and a tonsillectomy was later performed on (b)(6) 2011 due to no apparent response to clindamycin treatment. Mother indicated that the patient tested positive for strep a since the tonsillectomy, however it was not specified if this testing was performed with the quickvue test. No other diagnosis has been made regarding the patient's condition.
Patient Sequence No: 1, Text Type: D, B5
[16934770]
Manufacturer analyzed complaint data from the previous three (3) years. No trend was identified for false positive test results with the quickvue dipstick strep a product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024674-2011-00002 |
| MDR Report Key | 2338098 |
| Report Source | 00 |
| Date Received | 2011-11-07 |
| Date of Report | 2011-11-04 |
| Date of Event | 2011-04-01 |
| Date Mfgr Received | 2011-10-07 |
| Date Added to Maude | 2011-11-17 |
| 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 Street | 10165 MCKELLAR CT. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8585527910 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUICKVUE DIPSTICK STREP A TEST KIT |
| Generic Name | QUICKVUE DIPSTICK STREP A TEST KIT |
| Product Code | GTZ |
| Date Received | 2011-11-07 |
| Model Number | NA |
| Catalog Number | 20108 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Other | 2011-11-07 |