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 Inco..
[16271231]
A pt was tested using the group b strep assay lot number 690445. The perston reporting the incident believes but is not certain that the sample was obtained just prior to delivery of the infant. A duplicate specimen obtained at the same time was used to streak a culture plate. The result of the assay was negative. The culture result was positive for group b strep. The culture was confirmed with a strep typing kit, mfr unknown. The infant was very sick upon delivery and subsequently died. A blood culture from the infant was performed and the results were negative for group b strep. It was later determined that the infant died from asphyxia. 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022635-1996-00002 |
| MDR Report Key | 44798 |
| Report Source | 05 |
| Date Received | 1996-10-11 |
| Date of Report | 1996-10-11 |
| Date of Event | 1996-09-01 |
| Date Mfgr Received | 1996-09-17 |
| Device Manufacturer Date | 1996-05-01 |
| Date Added to Maude | 1996-10-29 |
| 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 |
| 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 | 45708 |
| Manufacturer | HYBRITECH INCO. |
| 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 | 1996-10-11 |