MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-20 for BOND-III 21.2201 manufactured by Leica Biosystems Melbourne Pty. Ltd.
[131145361]
The following information was documented for onsite review of the slide from the breast core biopsy sample stained for er in the run 3469 commencing on (b)(6) 2018, using the automated slide stainer bond-iii serial number (b)(4): "estrogen slide has strong intensity and percentage (80%), normal ducts were present and stained, external positive and negative control tissues were placed on the slide and stained as expected. " the following information was documented for onsite review of the slide from the breast core biopsy sample, cut at the same time with the (b)(6) staining, stained for er in the run 4616 commencing on (b)(6) 2018, using the automated slide stainer bond-iii serial number (b)(4): "estrogen is negative, normal ducts positive staining as expected. " the customer decided to re-cut slides to "avoid aging artifacts". The following information was documented for onsite review of the slide from the breast core biopsy sample, on a slide prepared just for oestrogen staining from the same biopsy, stained for er in the run 4645 commencing on (b)(6) 2018, using the automated slide stainer bond-iii serial number (b)(4): "estrogen negative, normal duct positive, external positive and negative control tissues (on the same slide) stained as expected. " the root cause of the er staining discrepancy between slides prepared from a breast core biopsy and stained in runs commencing on both (b)(6) 2018 using bond-iii automated slide stainer serial number (b)(4), as reported by the complainant, could not be attributed to the instrument from the information available. An additional er staining run, performed on (b)(6) 2018 on bond-iii automated slide stainer serial number (b)(4) using slide(s) re-cut from the original biopsy sample, showed the same staining as obtained from the run of (b)(6) 2018.
Patient Sequence No: 1, Text Type: N, H10
[131145362]
On (b)(6) 2018, the complainant advised leica biosystems that the results of ihc staining of slides prepared from a breast core biopsy samples on (b)(6) 2018 using bond-lll automated slide stainer serial number (b)(4), were er 80%, pgr negative, ki67 70% and c-erbb2 3+. The patient subsequently attended another clinical centre for surgery and the result for er in the excised tissue and nodes was negative. Repeat ihc staining of the original biopsy sample by the complainant showed er 0% and her2 negative (1-2+). On (b)(6) 2018, the leica field support representative (fss) assigned to this event documented the following information: "patient was treated trastuzumab so we wait for fish results for confirmation. " as at 04 december 2018, leica biosystems has not received further information from the complainant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020030-2018-00135 |
| MDR Report Key | 8187998 |
| Date Received | 2018-12-20 |
| Date of Report | 2019-01-18 |
| Date of Event | 2018-02-27 |
| Date Mfgr Received | 2019-01-14 |
| Device Manufacturer Date | 2017-01-11 |
| Date Added to Maude | 2018-12-20 |
| 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 | MRS ADRIENNE HARDISTY |
| Manufacturer Street | 495 BLACKBURN ROAD |
| Manufacturer City | MOUNT WAVERLEY, VIC 3149 |
| Manufacturer Country | AS |
| Manufacturer Postal | 3149 |
| Manufacturer G1 | LEICA BIOSYSTEMS MELBOURNE PTY. LTD |
| Manufacturer Street | 495 BLACKBURN ROAD |
| Manufacturer City | MOUNT WAVERLEY, VIC 3149 |
| Manufacturer Country | AS |
| Manufacturer Postal Code | 3149 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BOND-III |
| Generic Name | SLIDE STAINER |
| Product Code | KPA |
| Date Received | 2018-12-20 |
| Model Number | BOND-III |
| Catalog Number | 21.2201 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS MELBOURNE PTY. LTD |
| Manufacturer Address | 495 BLACKBURN ROAD MOUNT WAVERLEY, VIC 3149 AS 3149 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-20 |