MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-02-23 for NEOMARKERS RM9102-S, -S0,-S1 manufactured by Lab Vision Corp..
[20618156]
A complaint was raised by company's marketing mgr regarding catalog #rm-9102, neomarkers rabbit monoclonal anti-human progesterone receptor (pr) antibody, clone sp2 (sp2). The complaint reported the observation of false positive staining with sp2, when compared to another commercially available pr antibody. Although, the complaint of false positive staining has been raised, no death and adverse event have been reported. Our investigation of 4 batches reasonably confirmed the false positive staining problem of one specific batch, lot# 9102s509, of sp2.
Patient Sequence No: 1, Text Type: D, B5
[20831773]
Although, the complaint of false positive staining has been raised, no death and adverse event has been reported. However, in the interest of ensuring user safety and welfare, since december 2006 company decided to put sp2 products on hold (stop selling and stop shipment), and an advisory notice was issued and distributed to recipients of earlier shipments. The advisory notice has also been posted on company's website. To investigate the root cause of the suspected false positive staining problem associated with 9102s509 lot, we have contacted the raw material supplier of sp2, spring bioscience. We found the supplier changed the raw material of 9102s509 lot without informing us the change. The false positive staining problem may come from the change of raw material. We will further investigate the root cause of the false positive issue and file supplemental report later. In addition, company has started another study to compare the behavior of the current batch of sp2 and a predicate device. We expect to have the result in mid march 2007 and will file a supplemental report to fda if add'l info becomes available. In the meantime, we continue to hold and not sell the sp2 product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953151-2007-00001 |
| MDR Report Key | 827419 |
| Report Source | 07 |
| Date Received | 2007-02-23 |
| Date of Report | 2007-02-15 |
| Date Mfgr Received | 2007-02-13 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2007-03-15 |
| 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 | 47777 WARM SPRINGS BLVD |
| Manufacturer City | PREMONT CA 94539 |
| Manufacturer Country | US |
| Manufacturer Postal | 94539 |
| Manufacturer Phone | 5109912854 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOMARKERS |
| Generic Name | RABBIT MONOCLONAL ANTI-PR, CLONE SP2 |
| Product Code | MXZ |
| Date Received | 2007-02-23 |
| Model Number | NA |
| Catalog Number | RM9102-S, -S0,-S1 |
| Lot Number | 9102S509 |
| ID Number | NA |
| Device Expiration Date | 2007-09-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 814816 |
| Manufacturer | LAB VISION CORP. |
| Manufacturer Address | 47777 WARM SPRINGS BLVD. FREMONT CA 94539 US |
| Baseline Brand Name | NEOMARKERS |
| Baseline Generic Name | RABBIT MONOCLONAL ANTI-PR, CLONE SP2 |
| Baseline Model No | NA |
| Baseline Catalog No | RM9102-S, -S0,-S1 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-23 |