MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-12-16 for MEDI-LAB PERFORMANCE STREP A TEST-TWIST IST-502T manufactured by Biosite Incorporated.
[1275911]
Customer reported that two of the vocational students in the class incorrectly performed the strep a test-twist and ingested small amounts of reagent 1 and 2. According to the teacher, neither of the students involved read the package insert, but instead asked another student how to perform the test. Five drops of each reagent were added to the cup; swab was dipped into combined solution, and then applied to throat. Teacher indicated that they have read the package insert and noted the warnings and cautions. Students have been under observation for over one hour and no adverse symptoms have appeared.
Patient Sequence No: 1, Text Type: D, B5
[8426009]
Investigation in process to determine the adequacy of hazard warnings.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2009-01179 |
| MDR Report Key | 1573873 |
| Report Source | 04 |
| Date Received | 2009-12-16 |
| Date of Report | 2009-12-16 |
| Date of Event | 2009-11-18 |
| Date Mfgr Received | 2009-11-18 |
| Date Added to Maude | 2010-07-07 |
| 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 | CARMEN BERGELIN, MANAGER |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052256 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDI-LAB PERFORMANCE STREP A TEST-TWIST |
| Generic Name | STREP A TEST |
| Product Code | GTY |
| Date Received | 2009-12-16 |
| Model Number | IST-502T |
| Lot Number | NG |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSITE INCORPORATED |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-16 |