MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2018-06-01 for CLEARVIEW STREP A EXACT II DIPSTICK 30T IST-501 manufactured by Alere San Diego, Inc.
[109898568]
Investigation conclusion: false negative strep a results were not replicated in-house with retain products. Retain products were tested with strep a cutoff positive sample (2. 5e07org/ml). All results were positive at read time and met qc specifications. No false negative results were obtained during in-house testing. Manufacturing batch record review did not uncover any abnormalities. A negative result may be obtained if the concentration of the strep a antigen present in the throat swab is not adequate or is below the detectable level of the test. Based on the information available, there is no indication of a product deficiency and no corrective action is required.
Patient Sequence No: 1, Text Type: N, H10
[109898569]
On (b)(6) 2018, the patient presented at the urgent care facility with a sore throat. Upon the initial examination, the customer noted that the patient's throat only appeared a little red and it was not immediately evident the patient had strep a. A test was performed with a clearview strep a exact ii dipstick test using a dual swab technique and a negative result was obtained at the 5 minute read time. The second throat swab was sent to (b)(6) laboratory for culture confirmation. The patient was diagnosed with pharyngitis and sent home. Two hours after test was performed on the clearview strep a exact ii dipstick test, the operator noticed a faint positive line had developed in the test region and forwarded this information to the customer. On (b)(6) 2018, the customer contacted the patient to inform the patient of the positive result and prescribe amoxicillin. At this time, the throat culture results had not been received. On (b)(6) 2018, the customer obtained a positive result from the confirmatory throat culture. The report indicated that there were a few colonies of strep a on the culture. The culture was performed on strep a specific bacitracin disk. The customer proceeded to attempt to contact patient to inform of the positive confirmatory test and ensure the patient had begun the prescribed course of antibiotics. On (b)(6) 2018, the patient returned to the urgent care facility for an unrelated issue and was provided the results of the confirmatory throat culture. The patient subsequently began the prescribed amoxicillin. Troubleshooting was conducted with the customer. The customer was advised results should not be interpreted after the read time and a faint positive line after the read time may indicate the sample concentration is below the level of detection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2018-00068 |
| MDR Report Key | 7563182 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-06-01 |
| Date of Report | 2018-06-01 |
| Date of Event | 2018-04-27 |
| Date Mfgr Received | 2018-05-02 |
| Date Added to Maude | 2018-06-01 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEARVIEW STREP A EXACT II DIPSTICK 30T |
| Generic Name | STREP A RAPID TEST STRIP |
| Product Code | GTY |
| Date Received | 2018-06-01 |
| Model Number | IST-501 |
| Lot Number | STA7110016 |
| Device Expiration Date | 2019-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC |
| Manufacturer Address | 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-01 |