MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-12-26 for LEICA BIOSYSTEMS N/A PA0151 manufactured by Leica Biosystems Newcastle Ltd.
[131400505]
Initial investigations have uncovered that it is not the pa0151 product discordance that will have caused the possible incorrect treatment, but more the over scoring of another product manufactured by leica biosystems. Product ncl-l-cb11 was used to determine the her2 status of the patient sample in which the initial discrepancy was reported. A her2 score of 3+ was initially given and herceptin treatment prescribed. Further, post surgery testing (using a different product, roche 4b5) suggests a her2 status more in line with a 2+score, this indicates that further fish testing is required. Leica ncl-l-cb11 is a ce marked product to be used in a panel of antibodies. It is not designed or marketed for the use of her2 stratification. The recommended pretreatment is not being used in this case. Both the pretreatment and usage indicate off label use of this product. The cb11-l-ce is not listed in the u. S. Further fish testing is now being performed by the customer site to determine if the correct treatment has been prescribed. The fish result is currently unknown. It is not known why the initial pa0151 results differ, as information suggests that all controls performed as expected on all test runs.
Patient Sequence No: 1, Text Type: N, H10
[131400506]
Leica biosystems (b)(4) ltd received a complaint for contradictory results being achieved with leica pa0151 on the same patient case. The complaint states that it is possible that incorrect treatment has been administered as a result. The patient has received herceptin treatment. No further information has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004859032-2018-00001 |
| MDR Report Key | 8196243 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-12-26 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-02-27 |
| Date Mfgr Received | 2018-11-29 |
| Device Manufacturer Date | 2017-09-29 |
| Date Added to Maude | 2018-12-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS NATALIE HENDERSON |
| Manufacturer Street | BALLIOL BUSINESS PARK WEST BENTON LANE |
| Manufacturer City | NEWCASTLE, NE128EW |
| Manufacturer Country | UK |
| Manufacturer Postal | NE12 8EW |
| Manufacturer G1 | LEICA BIOSYSTEMS NEWCASTLE LTD |
| Manufacturer Street | BALLIOL BUSINESS PARK WEST BENTON LANE |
| Manufacturer City | NEWCASTLE, NE128EW |
| Manufacturer Country | UK |
| Manufacturer Postal Code | NE12 8EW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA BIOSYSTEMS |
| Generic Name | ESTROGEN RECEPTOR CLONE 6F11 READY-TO-USE PRIMARY ANTIBODY FOR BOND? |
| Product Code | MYA |
| Date Received | 2018-12-26 |
| Model Number | N/A |
| Catalog Number | PA0151 |
| Lot Number | 60139 |
| Device Expiration Date | 2019-03-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NEWCASTLE LTD |
| Manufacturer Address | BALLIOL BUSINESS PARK WEST BENTON LANE NEWCASTLE, NE128EW UK NE12 8EW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-26 |