MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2015-12-03 for HERCEPTEST SK001 manufactured by Dako Denmark A/s.
[32665054]
On 2015 (b)(6) biopsy stained with herceptest lot 20016932 at (b)(6) gave result her2 score 3+, strongly positive. Based upon the initial herceptest result, the patient was treated with herceptin. The patient did not respond to treatment and on 2015 (b)(6) patient was retested with surgical tissue stained with herceptest lot 20022527 and received her2 negative results. Moreover, on 2015 (b)(6) surgical tissue stained with zytolight spec her2/cen17 dual color probe at (b)(6) result: not her2 gene amplified. (dako complaint number (b)(4)).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610099-2015-00005 |
| MDR Report Key | 5266164 |
| Report Source | FOREIGN |
| Date Received | 2015-12-03 |
| Date of Report | 2015-12-03 |
| Date of Event | 2015-11-04 |
| Date Mfgr Received | 2015-11-04 |
| Device Manufacturer Date | 2015-02-13 |
| Date Added to Maude | 2015-12-03 |
| 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 | MS MONIKA BAK |
| Manufacturer Street | PRODUKTIONSVEJ 42 |
| Manufacturer City | GLOSTRUP, 2600 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2600 |
| Manufacturer Phone | 544859500 |
| Manufacturer G1 | DAKO DENMARK A/S |
| Manufacturer Street | PRODUKTIONSVEJ 42 |
| Manufacturer City | GLOSTRUP, COPENHAGEN 2600 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HERCEPTEST |
| Generic Name | HERCEPTEST FOR AUTOMATED LINK PLATFORMS |
| Product Code | MVC |
| Date Received | 2015-12-03 |
| Model Number | NA |
| Catalog Number | SK001 |
| Lot Number | 20016932 |
| Device Expiration Date | 2015-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAKO DENMARK A/S |
| Manufacturer Address | PRODUKTIONSVEJ 42 GLOSTRUP, 2600 DA 2600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-03 |