MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-06-30 for GS HIV-1 WESTERN BLOT 32508 manufactured by Bio-rad Laboratories.
[897681]
Bio-rad laboratories rec'd a call from the center for disease control in (b) (6), requesting info on the inactivation process for (b) (6) western blot low positive control. The customer was informed that the control material for the (b) (6) western blot is heat inactivated for 30 min at 56 degrees celsius and is certified to be non-reactive for (b) (6) and (b) (6) antibodies, which is the standard procedure for inactivation and the process has been validated. The caller stated that while discarding an old kit of (b) (6) western blot, a technician at cdc was splashed in the eye with the western blot low positive control. The technician, at the time, was wearing eye protection, but it did not seal around the face and the liquid splashed over the rim of the glasses. The technician used the eye wash station to flush the material from their eyes. At that time, the technician requested to be seen by a physician and was subsequently tested for (b) (6). Results of the testing are not known by bio-rad. The customer was reluctant to give any further info about future follow-up for fear it could compromise the technician's confidentiality.
Patient Sequence No: 1, Text Type: D, B5
[8085449]
The (b) (6) western blot package insert states on page 4, warnings for users, #4 the following "no known test method can offer complete assurance that infectious agents are absent. Therefore, all human blood derivatives, reagents and human specimens should be handled as if capable of transmitting infectious disease". Bio-rad laboratories is filing this report solely based on the statement in the (b) (6) western blot package insert and not because of any known defect of the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3022521-2008-00003 |
| MDR Report Key | 1068860 |
| Report Source | 05 |
| Date Received | 2008-06-30 |
| Date of Report | 2008-06-30 |
| Date of Event | 2008-06-04 |
| Date Mfgr Received | 2008-06-04 |
| Date Added to Maude | 2009-11-20 |
| 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 | CHRISTOPHER BENTSEN |
| Manufacturer Street | 6565 185TH AVE., N.E. |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4254981709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GS HIV-1 WESTERN BLOT |
| Generic Name | HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 |
| Product Code | MVW |
| Date Received | 2008-06-30 |
| Catalog Number | 32508 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-30 |