MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-17 for HERCEPTEST SK001 manufactured by Dako Denmark A/s.
[31453054]
Patient Sequence No: 1, Text Type: N, H10
[31453055]
A complaint has been received from a customer stating that a breast cancer specimen from a patient was interpreted as negative for her2 protein overexpression (0 staining intensity) when tested with two lots of sk001 ((b)(4)) but the same specimen was found to be her2 gene-amplified when tested with a fish-based assay. The customer reported that the dako-supplied control slide (with cancer cell lines 0, 1+, 3+) was working correctly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610099-2015-00003 |
| MDR Report Key | 5230954 |
| Date Received | 2015-11-17 |
| Date of Report | 2015-11-13 |
| Date of Event | 2015-10-19 |
| Date Mfgr Received | 2015-10-19 |
| Device Manufacturer Date | 2015-05-05 |
| Date Added to Maude | 2015-11-17 |
| 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 Contact | ROSANNE WELCHER |
| Manufacturer Street | 6392 VIA REAL |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| Manufacturer Phone | 8055665464 |
| Manufacturer G1 | DAKO DENMARK A/S |
| Manufacturer Street | 42 PRODUKTIONVEJ |
| Manufacturer City | GLOSTRUP, 2600 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HERCEPTEST |
| Generic Name | HERCEPTEST FOR AUTOMATED LINK PLATFORMS |
| Product Code | MVC |
| Date Received | 2015-11-17 |
| Catalog Number | SK001 |
| Lot Number | LOT 20020503 |
| Device Expiration Date | 2015-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAKO DENMARK A/S |
| Manufacturer Address | PRODUKTIONSVEJ 42 GLOSTRUP DENMARK 2600 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-17 |