MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-02-10 for BOND ORACLE HER2 IHC SYSTEM manufactured by Leica Biosystems Newcastle Ltd..
[38379346]
A review of the results and further testing by the healthcare professional demonstrated 3 pts samples may have given a false negative result. On 23rd january 2016, (b)(4) were given the following info: pt 1: (b)(6), female, mdr number: 3004859032-2016-00001. Pt 2: (b)(6), female, mdr number: 3004859032-2016-00002. Pt 3: (b)(6), female, mdr number: 3004859032-2016-00003. Mdr 3004859032-2015-00002 was raised following the complaint. The report has been ongoing as the investigation required further info from the customer.
Patient Sequence No: 1, Text Type: N, H10
[38379347]
(b)(4) was informed on september 14, 2015 that 2 batches of bond oracle her2 ihc system - product code ta9145 (lots 27595 and 20871) were used for testing pt samples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004859032-2016-00002 |
| MDR Report Key | 5440961 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-02-10 |
| Date of Report | 2016-01-23 |
| Date of Event | 2015-09-14 |
| Date Mfgr Received | 2015-09-14 |
| Date Added to Maude | 2016-02-17 |
| 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 Street | BALLIOL BUSINESS PARK WEST BENTON LANE |
| Manufacturer City | NEWCASTLE |
| Manufacturer Country | UK |
| Manufacturer Phone | 912154736 |
| 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 | 2016-02-10 |
| Lot Number | 20871 AND 27595 |
| 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 NE128EW UK NE12 8EW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-02-10 |