MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-13 for HERCEPTEST FOR THE DAKO AUTOSTAINER K5207 manufactured by Dako Denmark A/s.
[111455017]
As part of dako's internal audit and continuous improvement process, dako performed an internal review of complaints beginning with those initiated january 1, 2015. This report is based on that review as complaint (b)(4) was determined to be mdr reportable. It is therefore being filed with the fda retrospectively. This is an initial and final report combined. The investigation for this case was closed in 2016, but during review the case has been reopened and reassessed as part of the internal review.
Patient Sequence No: 1, Text Type: N, H10
[111455018]
Device involved in this complaint:? K5207, herceptest for dako autostainer. Summary: inconsistent staining on product k5207/herceptest for the dako autostainer, lot no. 20029667, resulted in a false negative. The customer reran the patient tissue on the herceptest assay which confirmed the negative test result. The customer also ran a fish test on the patient tissue which resulted in a positive result. No misdiagnosis occurred as the patient was diagnosed according to the fish testing. Assessment: the customer ran a fish on the specific patient tissue after the ihc tissue test and retest resulted as negative for her2. The fish test indicated the tissue was positive. The customer indicated they thought their procedure was the cause of negative tests. A service engineer was sent on site to work with the customer. The service engineer confirmed their procedure. No root cause or likely root cause was identified. The serial number of the autostainer was not recorded in the complaint. As part of its internal review, dako analyzed whether there were any additional complaints logged on the customer's lot number and no other complaints were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610099-2018-00002 |
| MDR Report Key | 7598042 |
| Date Received | 2018-06-13 |
| Date of Report | 2018-06-13 |
| Date of Event | 2016-05-09 |
| Date Mfgr Received | 2016-05-09 |
| Device Manufacturer Date | 2015-12-18 |
| Date Added to Maude | 2018-06-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NANNA AAKARD |
| Manufacturer Street | PRODUKTIONSVEJ 42 |
| Manufacturer City | GLOSTRUP, 2600 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2600 |
| Manufacturer G1 | DAKO DENMARK A/S |
| Manufacturer Street | PRODUKTIONSVEJ 42 |
| 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 FOR THE DAKO AUTOSTAINER |
| Generic Name | HERCEPTEST FOR THE DAKO AUTOSTAINER |
| Product Code | MVC |
| Date Received | 2018-06-13 |
| Catalog Number | K5207 |
| Lot Number | 20029667 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-06-13 |