MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-11-04 for ADVIA CENTAUR HIV 1/O/2 ENHANCED ASSAY 01622429 manufactured by Siemens Healthcare Diagnostics Inc..
[978340]
A laboratory technician accidentally stuck herself with a needle. A blood sample from this technician was tested for using the advia centaur hiv 1/o/2 enhanced assay. The initial and repeat results were both reactive. Supplemental confirmatory testing was performed and the results were non-reactive. A new blood sample was drawn from the lab technician and the advia centaur 1/o/2 enhanced assay result was reactive whereas the confirmatory result was non-reactive. The laboratory technician was administered gamma globulin and combovere.
Patient Sequence No: 1, Text Type: D, B5
[8209105]
The instruction for use clearly states that repeatedly reactive specimens on the advia centaur must be investigated using supplemental tests. This event is being reported because the lab tech was administered treatment based on the reactive results. No further eval of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2008-00089 |
| MDR Report Key | 1221828 |
| Report Source | 05 |
| Date Received | 2008-11-04 |
| Date of Report | 2008-09-29 |
| Date of Event | 2008-09-17 |
| Date Mfgr Received | 2008-09-29 |
| Date Added to Maude | 2009-06-05 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY ST. |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY ST. |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR HIV 1/O/2 ENHANCED ASSAY |
| Generic Name | EHIV IMMUNOASSAY |
| Product Code | MVW |
| Date Received | 2008-11-04 |
| Model Number | NA |
| Catalog Number | 01622429 |
| Lot Number | 141 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-04 |