MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2008-03-12 for BIOSTAR OIA STREP B * GBS30 manufactured by Inverness Medical-biostar Inc.
[21699477]
Lab reported mother was screened for group b strep using the biostar oia strep b assay during labor. Vaginal specimen was taken according to directions for use/package insert. Separate specimen was taken for culture. Oia rapid assay was negative; no prophylactic antibiotic was administered. Infant developed respiratory distress following birth, and died the following day. Autopsy indicated gbs sepsis.
Patient Sequence No: 1, Text Type: D, B5
[21823806]
Initial assessment: device performed within specification (reference package insert). In clinical trials, oia negative 66% when 24hr direct culture also negative, oia positive 34% when only broth amplification positive. Clinical specimen most probably below limit of detection of assay. Device evaluation (returned & retained devices): unable to confirm complaint; retention devices perform within specification at limit of detection. Returned devices show significant damage to surfaces, including pre-assay surfaces, making low end interpretation difficult. However, positive signals were obtained with one colony from swab of agar culture and with low/moderate standards. Returned devices performed within release specifications, but it is noted that significant surface damage not present on retained kit made interpretation more difficult on returned devices. Surface damage was not reported as a part of the complaint, and the lab is proficient with oia assay. Follow-up with lab indicated controls performed as expected, no surface damage reported. Surface damage most likely occurred during return shipping and did not contribute to lab's negative result.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1720655-2007-00001 |
| MDR Report Key | 1012565 |
| Report Source | 00,06 |
| Date Received | 2008-03-12 |
| Date of Report | 2008-03-12 |
| Date of Event | 2007-04-01 |
| Date Mfgr Received | 2007-04-04 |
| Date Added to Maude | 2008-03-17 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 331 SOUTH 104TH STREET |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal | 80027 |
| Manufacturer Phone | 3035303888 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOSTAR OIA STREP B |
| Generic Name | RAPID IMMUNOASSAY FOR GR. B STREP |
| Product Code | GTY |
| Date Received | 2008-03-12 |
| Returned To Mfg | 2007-04-16 |
| Model Number | * |
| Catalog Number | GBS30 |
| Lot Number | 176180 |
| ID Number | * |
| Device Expiration Date | 2007-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 980073 |
| Manufacturer | INVERNESS MEDICAL-BIOSTAR INC |
| Manufacturer Address | * LOUISVILLE CO 80027 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-03-12 |