MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-09-08 for PROBECHEK UROVYSION CONTROL SLIDES 02J27-011 (30-805070) manufactured by Abbott Molecular, Inc..
[1590089]
The probechek urovysion control slides are non-hybridized slides prepared with cultured normal male lymphoblast cells and cultured bladder cancer cell lines. Each control slide consists of two separate target areas in which each of the different cell types have been applied. The cell lines are harvested, fixed in suspension medium and applied to the glass microscope slides in a method optimal for fish ( fluorescence in situ hybridization). A customer complaint that 3 of 15 probechek urovysion control slide kits (b)(4) lot# 422286 contained broken slides upon receipt. Customer stated that there was no obvious damage to the outer packaging. Each kit lot 422286 contains 3 slides each, (b)(4) lot 421700. Per probechek control slides for fluorescence in situ hybridization (fish) using urovysion bladder cancer kit package insert (b)(4): "the probechek controls and all other fresh or fixed specimens should be handled as if capable of transmitting infectious agents. Dispose of with proper precautions. Because it is often impossible to know which might be infectious, all specimens are to be treated with universal precautions. " no harm or injuries occurred to the customer.
Patient Sequence No: 1, Text Type: D, B5
[8782718]
Visual inspection of the customer's returns identified no damage to the plastic slide boxes; however, broken slides were noted inside the boxes as follows: in box #1 and box #2, 1 of 3 slides was broken in each box; in box #3, all 3 slides were broken. Inspection from qc retention sample from the lot in question did not identify any issues. No related complaints or capa were identified for this material. Based on the overall investigation, the incident appears to be an isolated incident that may have occurred in transit of the material to the customer site. No product deficiency has been identified to date.
Patient Sequence No: 1, Text Type: N, H10
[10298222]
On (b)(6), 2012, through an internal audit investigation it was discovered that some dates included in the original mdr report were missing or incorrect. The purpose of this mdr follow-up report #1 is to update the missing or incorrect dates as follows:(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2010-00003 |
| MDR Report Key | 1828130 |
| Report Source | 07 |
| Date Received | 2010-09-08 |
| Date of Report | 2010-05-05 |
| Date of Event | 2010-05-05 |
| Date Mfgr Received | 2012-10-19 |
| Device Manufacturer Date | 2009-12-08 |
| Date Added to Maude | 2011-06-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS PAMELA SWATKOWSKI |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617013 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROBECHEK UROVYSION CONTROL SLIDES |
| Generic Name | MICROSCOPIC CONTROL SLIDES USED IN FISH TESTING |
| Product Code | MMW |
| Date Received | 2010-09-08 |
| Returned To Mfg | 2010-05-10 |
| Catalog Number | 02J27-011 (30-805070) |
| Lot Number | 422286 |
| Device Expiration Date | 2010-11-09 |
| Operator | OTHER |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 EAST TOUHY AVENUE DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-08 |