MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2009-06-01 for PSS SELECT STREP A DIPSTICK IST-501-OBC507 manufactured by Biosite Inc..
[21324967]
Investigation: product lot: sta7080127 (exp. Date: 2009/08). Summary of results: according to the complaint info, retained strips were tested with qc positive standards and positive control; all strips yielded positive results and met qc specifications. The results above indicate that the complaint was not confirmed. It is possible that the strep a present was below the detectable level of the test, which may cause a negative result. The product number, product description, lot number and batch record were verified. No abnormal results were found in the batch record review. No corrective action required as no product deficiency was established.
Patient Sequence No: 1, Text Type: N, H10
[21426974]
In 2009- customer complained of false negative results on pss strep a test. It showed positive only after 1 to 2 hours. Various pt swabs were compared to a culture sent to the lab, and the lab results came back as positive.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2009-00381 |
| MDR Report Key | 1446094 |
| Report Source | 07,08 |
| Date Received | 2009-06-01 |
| Date of Report | 2009-06-01 |
| Date of Event | 2009-05-05 |
| Date Mfgr Received | 2009-05-05 |
| Date Added to Maude | 2009-10-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CARMEN BERGELIN, MGR. |
| Manufacturer Street | 9975 SUMMERS RIDGE RD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052256 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PSS SELECT STREP A DIPSTICK |
| Generic Name | STREP A TEST |
| Product Code | GTY |
| Date Received | 2009-06-01 |
| Model Number | IST-501-OBC507 |
| Lot Number | STA7080127 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSITE INC. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-01 |