MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-12-10 for STREP A RAPID TEST STRIP (THROAT SWAB) IST-501 manufactured by Alere San Diego, Inc..
[129889923]
Investigation conclusion: an investigation was performed on retention devices from the reported lot number. Retention devices were tested with qc positive standards (2. 5e7 org/ml). Results were read at 5 minutes and all devices yielded expected positive results. No false negative results were observed during in-house testing. Manufacturing batch record review did not uncover any abnormalities and found that the lot met quality control specifications. A root cause could not be determined from the available information. 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. Therefore, it is recommended that a negative result obtained from this kit be confirmed by culture.
Patient Sequence No: 1, Text Type: N, H10
[129889924]
Unconfirmed false negative result on the strep a rapid test strip. Patient's condition worsened as a result of the false negative result obtained and patient was hospitalized with complications. Unknown if confirmatory testing was performed. Although further information was requested, no further information was able to be obtained from the complainant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2018-00166 |
| MDR Report Key | 8149379 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-12-10 |
| Date of Report | 2018-11-13 |
| Date Mfgr Received | 2018-11-13 |
| Date Added to Maude | 2018-12-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 RD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STREP A RAPID TEST STRIP (THROAT SWAB) |
| Generic Name | STREP A TEST |
| Product Code | GTY |
| Date Received | 2018-12-10 |
| Model Number | IST-501 |
| Lot Number | STA7100023 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | 9975 SUMMERS RIDGE RD. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-12-10 |