MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-12-04 for ICON GROUP B STREP ASSAY 4520 manufactured by Hybritech Inc..
[19959075]
Report was received regarding two female labor and delivery pts. Both were tested using the group b strep assay lot number 690633. Results of both tests were negative. Duplicate specimens obtained at the same time were cultured with positive group b strep heavy growth results. Circumstances regarding why the testing was performed is not known. Person reporting incident believes that the babies were fine. No samples were received from the customer for testing; therefore, the complaints for culture posititive, asst negative could not be evaluated. An open kit lot number 690633 was received from the customer and tested at co. Testing was performed using the returned kit. Negative control, positive control, and a sensitivity sample were tested and produced the following results: sample; expected result; result: negative control; visually negative; visually negative: positive control; visually positive; visually positive: sensitivity sample; visually positive; visually positive. Based on the info obtained by co to date, no death or serious injury has occurred because of this possible malfunction. Co has no plans to submit add'l info pertaining to this mdr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022635-1996-00011 |
| MDR Report Key | 54574 |
| Report Source | 05 |
| Date Received | 1996-12-04 |
| Date of Report | 1996-12-04 |
| Date Mfgr Received | 1996-11-12 |
| Device Manufacturer Date | 1996-07-01 |
| Date Added to Maude | 1996-12-12 |
| 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 GROUP B STREP ASSAY |
| Generic Name | GBS TEST |
| Product Code | GTZ |
| Date Received | 1996-12-04 |
| Model Number | NA |
| Catalog Number | 4520 |
| Lot Number | 690633 |
| ID Number | NA |
| Device Expiration Date | 1997-05-15 |
| 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 | 55133 |
| Manufacturer | HYBRITECH INC. |
| Manufacturer Address | 8958 TERMAN CT PO 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 | 1996-12-04 |