MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-03-09 for BOND AND NOVOCASTRA NCL-ER-6F11 manufactured by Leica Biosystems Newcastle Ltd.
[2404129]
Customer raised query ((b)(4)) regarding potential false positive results obtained using leica estrogen receptor clone ((b)(4)). Discordant results were reported on a retrospective validation cohort when compared with staining results obtained with competitor er antibody. The same staining pattern was subsequently observed in pt samples and the hospital has suspended er testing service resulting in a potential delay in pt diagnosis.
Patient Sequence No: 1, Text Type: D, B5
[9696676]
Review of the slides from (b)(6) hospital and subsequent assessment at (b)(6) has confirmed that the protocol at (b)(6) hospital, which employed a more aggressive pretreatment, is the most likely cause of staining pattern noted at by the customer. When an appropriate epitope retrieval buffer was employed the staining was not observed. Advised customer to revalidate the antibody using the appropriate epitope retrieval solution. The complaint is still under investigation. A follow-up report will be submitted after we complete our investigations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004859032-2012-00002 |
| MDR Report Key | 2492795 |
| Report Source | 04 |
| Date Received | 2012-03-09 |
| Date of Report | 2012-03-08 |
| Date of Event | 2012-02-01 |
| Date Mfgr Received | 2012-02-01 |
| Device Manufacturer Date | 2012-01-11 |
| Date Added to Maude | 2012-08-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | BENTON LANE BALLIOL BUSINESS PARK |
| Manufacturer City | NEWCASTLE UPON TYNE NE128EW |
| Manufacturer Country | UK |
| Manufacturer Postal | NE12 8EW |
| Manufacturer Phone | 912150567 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOND AND NOVOCASTRA |
| Generic Name | IMMUNOHISTOCHEMISTRY REAGENT |
| Product Code | MYA |
| Date Received | 2012-03-09 |
| Model Number | NCL-ER-6F11 |
| Catalog Number | NCL-ER-6F11 |
| Lot Number | 6008295 |
| Device Expiration Date | 2014-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NEWCASTLE LTD |
| Manufacturer Address | BENTON LANE BALLIOL BUSINESS PARK NEWCASTLE UPON TYNE NE128EW UK NE12 8EW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-09 |