MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,unknow report with the FDA on 2015-10-13 for BOND? ORACLE? HER2 IHC SYSTEM N/A TA9145 manufactured by Leica Biosystems Newcastle Ltd..
[28502488]
Leica biosystems was informed on 09/14/2015 that 2 batches of bond oracle her2 ihc system were used for testing patient samples. A review of the results and further testing by the healthcare professional demonstrated 3 patients samples may have given a false negative result.
Patient Sequence No: 1, Text Type: D, B5
[39147504]
Leica biosystems was informed on (b)(6) 2015, that 2 batches of bond oracle her2 ihc system - product code ta9145 (lots 27595 and 20871) were used for testing patient samples. A review of the results and further testing by healthcare professional demonstrated 3 patients samples may have given a false negative result. Leica biosystems new castle ltd have requested further information to aid in the investigation, to date no information has been received.
Patient Sequence No: 1, Text Type: D, B5
[39160470]
On (b)(4) 2016, leica biosystems were given the following information. Images of cell lines from lot 27595 have been sent to the (b)(4) facility to review. Further correspondence is to be sent to the customer to request the in house control slides, patient samples and cell lines for lots under complaint. This will aid the investigation.
Patient Sequence No: 1, Text Type: N, H10
[54909856]
The patient and control slides have been returned to the manufacturer. The patient slides demonstrate positive staining which indicates a positive result for her2. The product has performed as intended and indicates no malfunction. The customer confirmed the product lot which was used for the 3 patient slides was 27595. The device had been utilised.
Patient Sequence No: 1, Text Type: N, H10
[54909857]
Leica biosystems was informed on 14 september 2015 that 2 batches of bond? Oracle? Her2 ihc system - product code ta9145 (lots 27595 and 20871) were used for testing patient samples. A review of the results and further testing by the healthcare professional demonstrated 3 patients samples may have given a false negative result.
Patient Sequence No: 1, Text Type: D, B5
[39160471]
On (b)(4) 2016, leica biosystems were given the following information. Images of cell lines from lot 27595 have been sent to the (b)(4) facility to review. Further correspondence is to be sent to the customer to request the in house control slides, patient samples and cell lines for lots under complaint. This will aid the investigation.
Patient Sequence No: 2, Text Type: N, H10
[39160472]
On (b)(4) 2016, leica biosystems were given the following information. Images of cell lines from lot 27595 have been sent to the (b)(4) facility to review. Further correspondence is to be sent to the customer to request the in-house control slides, patient samples and cell lines for lots under complaint. This will aid the investigation.
Patient Sequence No: 3, Text Type: N, H10
| Report Number | 3004859032-2015-00002 |
| MDR Report Key | 5153141 |
| Report Source | COMPANY REPRESENTATIVE,UNKNOW |
| Date Received | 2015-10-13 |
| Date Mfgr Received | 2015-09-14 |
| Device Manufacturer Date | 2014-07-24 |
| Date Added to Maude | 2015-10-15 |
| 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 | 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 Phone | 2154736 |
| 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 | BOND? ORACLE? HER2 IHC SYSTEM |
| Generic Name | BOND? ORACLE? HER2 IHC SYSTEM |
| Product Code | MVC |
| Date Received | 2015-10-13 |
| Model Number | N/A |
| Catalog Number | TA9145 |
| Lot Number | 27595 |
| Device Expiration Date | 2015-07-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NEWCASTLE LTD. |
| Manufacturer Address | BALLIOL BUSINESS PARK WEST BENTON LANE NEWCASTLE UPON TYNE, NE128EW UK NE12 8EW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-13 |
| 2 | 0 | 2015-10-13 | |
| 3 | 0 | 2015-10-13 |