MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-18 for LEICA BIOSYSTEMS TA9145 manufactured by Leica Biosystems Newcastle Ltd..
[32363830]
Leica biosystems (b)(4) received a complaint to state bond oracle her2 ihc system ta9145 batch 30140 to state the following: "there is a lot more background staining than usual and not as crisp as it used to be. Also, the membranous "chicken wire staining is not continuous, it appears broken up". This resulted in the re biopsy of 3 patients. The product has been requested to be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
[37073319]
This product is to be returned to leica biosystems newcastle ltd to perform testing. The retained unit has been tested according to the ifu/dmr, no issues were observed when testing w/known positive control samples, both tissue and cell lines (cell lines are provided with the oracle kit). No further actions at this time until the customer unit has been returned for testing.
Patient Sequence No: 1, Text Type: N, H10
[40749295]
The customer have confirmed they have destroyed the unit therefore, further testing could not be performed. The retained unit had been tested according to the ifu/dmr, no issues were observed when testing with known positive control samples, both tissue and cell lines (cell lines are provided with the oracle kit). .
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004859032-2015-00003 |
| MDR Report Key | 5249572 |
| Date Received | 2015-11-18 |
| Date of Report | 2015-11-18 |
| Date of Event | 2015-10-30 |
| Date Mfgr Received | 2015-10-30 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2015-11-25 |
| 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 | NATALIE HENDERSON |
| Manufacturer Street | BALLIOL BUSINESS PARK WEST BENTON LANE |
| Manufacturer City | NEWCASTLE UPON TYNE |
| Manufacturer Country | UK |
| Manufacturer Phone | 912154736 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA BIOSYSTEMS |
| Generic Name | BOND ORACLE HER2 IHC SYSTEM |
| Product Code | MYA |
| Date Received | 2015-11-18 |
| Catalog Number | TA9145 |
| Lot Number | 30140 |
| Device Expiration Date | 2016-02-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-11-18 |