MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-04 for LEICA BIOSYSTEMS DS9390 manufactured by Leica Biosystems Newcastle Ltd.
[33293109]
The complaint was initially reviewed and determined to be non reportable as there was no obvious malfunction. It was believed it did not work correctly due to the customer using a different protocol than what is stated in the info for use booklet. The retained unit was also tested and found to work optimally. The customer kit was returned and tested, which then led to the understanding the product did malfunction. An investigation was performed and a recall of the affected products is now underway. The root cause of the malfunction is a manual fill of the product has been conducted with the incorrect component.
Patient Sequence No: 1, Text Type: N, H10
[33293110]
On (b)(6) 2015, leica (b)(4) received a complaint regarding ds9390 bond polymer refine red detection batch 41919 to state there was no staining observed when using this product. The customer was noted to use the product following a different protocol to what is specified in the info for use booklet. The product was returned for analysis and found to not perform correctly when tested using the correct protocol. The testing was concluded on (b)(6) 2015. This is the date the root cause was identified as a malfunction with the product.
Patient Sequence No: 1, Text Type: D, B5
[40682356]
A product recall was initiated on 11/16/2015, of (b)(4) batches of (b)(4) bond polymer refine red detection which have the potential to be affected by the same failure mode as this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004859032-2015-00004 |
| MDR Report Key | 5273523 |
| Date Received | 2015-12-04 |
| Date of Report | 2015-11-09 |
| Date of Event | 2015-10-09 |
| Date Mfgr Received | 2015-10-09 |
| Device Manufacturer Date | 2015-08-01 |
| Date Added to Maude | 2015-12-08 |
| 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 |
| Manufacturer City | NEWCASTLE NE128EW |
| Manufacturer Country | UK |
| Manufacturer Postal | NE12 8EW |
| Manufacturer Phone | 912154736 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 1423337-16-11-2015-005-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA BIOSYSTEMS |
| Generic Name | BOND POLYMER REFINE RED DETECTION |
| Product Code | NJT |
| Date Received | 2015-12-04 |
| Returned To Mfg | 2015-10-20 |
| Catalog Number | DS9390 |
| Lot Number | 41619 |
| Device Expiration Date | 2016-10-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NEWCASTLE LTD |
| Manufacturer Address | BELLIOL BUSINESS PARK WEST BENTON LANE, NEWCASTLE NE128EW UK NE12 8EW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-04 |