MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-10-11 for ICON IMMUNOCONCENTRATION ASSAY FOR GROUP B STREP 4520 manufactured by Hybritech Inc..
[27348]
Info was received regarding a pt tested intrapartum using the device gbs assay lot number 690445. The pt was tested during labor at 5:30 am and during delivery at 11:30 pm on 9/8/96. Duplicate specimens obtained at the same time were used to streak culture plates. The results of the assays were negative. No antibiotic treatment was administered to the pt based on the results. The culture results were positive for group b strep. The cultures were confirmed with a strep typing kit, mfr unknown and by backtyping using the gbs assay. The infant delivered from this pt was sent to the neonatal unit due to respiratory distress. The blood culture from this infant was positive for gbs. The infant is now doing fine. No sample or kit was received from the customer for testing; therefore, the complaint for culture positive, negative could not be evaluated. Testing was performed at co using an in-house kit of the same lot number. Refer to section h10 for test results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022635-1996-00003 |
| MDR Report Key | 42393 |
| Report Source | 05 |
| Date Received | 1996-10-11 |
| Date of Report | 1996-10-11 |
| Date of Event | 1996-09-08 |
| Date Mfgr Received | 1996-09-17 |
| Device Manufacturer Date | 1996-05-01 |
| Date Added to Maude | 1996-10-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICON IMMUNOCONCENTRATION ASSAY FOR GROUP B STREP |
| Generic Name | GBS TEST |
| Product Code | GTZ |
| Date Received | 1996-10-11 |
| Model Number | NA |
| Catalog Number | 4520 |
| Lot Number | 690445 |
| ID Number | NA |
| Device Expiration Date | 1997-01-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 43424 |
| Manufacturer | HYBRITECH INC. |
| Manufacturer Address | 8958 TERMAN COURT P.O. BOX 269006 SAN DIEGO CA 921969006 US |
| Baseline Brand Name | ICON STREP B |
| Baseline Generic Name | IMMUNOCONCENTRATION ASSAY FOR DETECTION & CONFIRMATION OF GBS FROM VAGINAL & CER |
| Baseline Model No | * |
| Baseline Catalog No | 4520 |
| Baseline ID | NA |
| Baseline Device Family | ICON |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K902991 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-10-11 |