MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-23 for LEICA BIOSYSTEMS PB0829 manufactured by Leica Biosystems Newcastle Ltd.
[34934467]
The customer informed leica biosystems newcastle ltd that the tissue was stained again with a different unit of pb0829 from a different lot and demonstrated the correct staining. A diagnosis was made without having to perform a re biopsy, but there was a delay due to retesting the patient tissue. This product is sold as an analyte specific reagent in the us.
Patient Sequence No: 1, Text Type: N, H10
[34934468]
Leica biosystems received a complaint regarding a (b)(6) high risk probe (product code pb0829) not staining on a known positive control. The complaint stated 5 different positive controls had been used and demonstrated negative staining.
Patient Sequence No: 1, Text Type: D, B5
[38883782]
The retained unit has been tested at the (b)(4) facility using a known hpv positive tissue and appropriate reagent controls. No issues were observed with the resulting sections. The negative and positive controls were as expected. No further action required. The customer has been contacted several times to send back their unit but the customer has decided not to return the unit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004859032-2015-00005 |
| MDR Report Key | 5332286 |
| Date Received | 2015-12-23 |
| Date of Report | 2015-11-27 |
| Date of Event | 2015-11-27 |
| Date Mfgr Received | 2015-11-27 |
| Device Manufacturer Date | 2014-11-19 |
| Date Added to Maude | 2015-12-29 |
| 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 | NATALIE HENDERSON |
| Manufacturer Street | BALLIOL BUSINESS PARK WEST BENTON LANE |
| Manufacturer City | NEWCASTLE NE128EW |
| Manufacturer Country | UK |
| Manufacturer Postal | NE12 8EW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA BIOSYSTEMS |
| Generic Name | BOND READ-TO-USE ISH HPV PROBE |
| Product Code | MVU |
| Date Received | 2015-12-23 |
| Catalog Number | PB0829 |
| Lot Number | 29078 |
| Device Expiration Date | 2016-02-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-12-23 |