MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-07 for LEICA BIOSYSTEMS PB0780 manufactured by Leica Biosystems Newcastle Ltd.
[28154570]
Leica (b)(4) received a complaint on (b)(6) 2015 regarding a false positive result obtained with a hpv probe (product code pb0780). The samples and also the negative controls all demonstrated positive staining. The customer re ran the tests with 2 other vials of product (therefore using 3 separate vials in total) and obtained the same results. All three vials used in testing were from lot 30241. On (b)(6) 2015, leica (b)(4) received info that tissue from 1 pt demonstrated false positive staining. The pt tissue has been tested 3 times in total. This took 3 weeks. The diagnosis was therefore delayed for 3 weeks and was finally reported as negative.
Patient Sequence No: 1, Text Type: D, B5
[67575591]
When serial sections of (b)(6) skin sample (tissue id (b)(6)) were stained using both the customer returned and retained units of the batch (pb0780, 30241), no issues with (b)(6) staining were observed. Both probes yielded staining of an appropriate and acceptable intensity and pattern. No non-specific or background staining was observed. The dna (b)(6) and dna (b)(6) controls also stained as expected, providing further confidence of the presence of (b)(6) cells. Whilst the customer uses (b)(6) control tissue, they do not use dna controls. This would help provide more information regarding the staining pattern of any tissue used. No further action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004859032-2015-00001 |
| MDR Report Key | 5141826 |
| Date Received | 2015-10-07 |
| Date of Report | 2015-10-05 |
| Date of Event | 2015-09-09 |
| Device Manufacturer Date | 2015-02-01 |
| Date Added to Maude | 2015-10-09 |
| 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 Street | BENTON LANE BALLIOL BUSINESS PARK WEST |
| Manufacturer City | NEWCASTLE UPON TYNE NE128EW |
| Manufacturer Country | UK |
| Manufacturer Postal | NE12 8EW |
| Manufacturer Phone | 912154736 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA BIOSYSTEMS |
| Generic Name | HPV PROBE (SUBTYPES 6, 11) |
| Product Code | MVU |
| Date Received | 2015-10-07 |
| Returned To Mfg | 2015-09-18 |
| Catalog Number | PB0780 |
| Lot Number | 30241 |
| Device Expiration Date | 2017-07-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NEWCASTLE LTD |
| Manufacturer Address | BENTON LANE BALLIOL BUSINESS PARK WEST NEWCASTLE UPON TYNE NE128EW UK NE12 8EW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-07 |