MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-08-27 for BOND ORACLE HER2 IHC SYSTEM TA9145 manufactured by Leica Biosystems Newcastle Ltd..
[3815796]
The new oracle kit (lot 20500) was started and the lab staff felt the staining on the cell line was a little weaker than normal, but acceptable, and they continued to use the kit. The first two runs they were happy with. The next two runs were rejected as the cell lines were staining very weakly. The first rejected run was stained on freddie (b)(4). The control slide (b)(4) showed some very weak membrane staining in the 1+ and 2+ was also weak with less cells staining than expected. The in house control was ok. On the second rejected run straining on geoffrey (b)(4), the control slide (b)(4) staining was even weaker. The 1 + was negative for membrane staining with very weak brush borders. The 2+ and 3+ were also very weakly stained. The in house control was weak but still gave 1+, 2+ and 3+. At this point, the site contacted the leica field support scientist and also opened a new kit to run as a comparison (run on freddie). This kit (lot 201437) stained fine (controls (b)(4) stained as expected). The cases from the rejected runs have been repeated with this new kit. As a result of the observed staining by the customer, there was a two day delay in diagnosis.
Patient Sequence No: 1, Text Type: D, B5
[11201105]
The kit was returned to leica biosystems (b)(4) and internal testing has been carried out. The returned customer kit was tested against a retained unit of the same lot and also against the lot which the customer is now using. Although results for lot 20500 show a difference in staining between the retained and returned kits with regards to cell lines (within acceptable limits) the in house control and test slides are comparable. Despite the slight difference in control intensity, the test section consistently scores 1+ and the outcome for the pt would not change over the 3 kits tested. Therefore, there would be no risk of potential injury to the pt using the results observed by the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004859032-2013-00001 |
| MDR Report Key | 3350421 |
| Report Source | 07 |
| Date Received | 2013-08-27 |
| Date of Report | 2013-08-02 |
| Date of Event | 2013-07-29 |
| Date Mfgr Received | 2013-08-02 |
| Device Manufacturer Date | 2013-02-20 |
| Date Added to Maude | 2013-11-27 |
| 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 LN. BALLIOL BUSINESS PARK W. |
| Manufacturer City | NEWCASTLE UPON TYNE NE128EW |
| Manufacturer Country | UK |
| Manufacturer Postal | NE12 8EW |
| Manufacturer Phone | 92150567 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOND ORACLE HER2 IHC SYSTEM |
| Generic Name | NONE |
| Product Code | MVC |
| Date Received | 2013-08-27 |
| Returned To Mfg | 2013-08-13 |
| Model Number | TA9145 |
| Lot Number | 20500 |
| Device Expiration Date | 2013-12-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2013-08-27 |