MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-05-20 for PROBECHEK UROVYSION CONTROL SLIDES 02J27-011 manufactured by Abbott Molecular, Inc..
[17882838]
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). Customer opened box and saw that two slides were broken. Customer stated that she received package with no obvious damage to carton; upon opening urovysion control slides, customer saw that two out of the three slides were broken. Customer immediately closed the box. There was no injury. 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. Guidelines for specimen handling are available from the u. S. Centers for disease control and prevention. Material safety data sheets (msds) on all materials supplied in the probechek controls are available from the abbott molecular technical service department. Avoid contact of probechek slides with skin and mucous membranes. "
Patient Sequence No: 1, Text Type: D, B5
[18019303]
Abbott molecular is currently investigating this complaint. A follow up report will be submitted once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2011-00007 |
| MDR Report Key | 2370306 |
| Report Source | 07 |
| Date Received | 2011-05-20 |
| Date of Report | 2011-05-20 |
| Date of Event | 2011-04-26 |
| Date Mfgr Received | 2011-04-26 |
| Date Added to Maude | 2012-04-06 |
| 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 | MR DIMITRIS DEMIRTZOGLOU |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617975 |
| 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 | 0 |
| Remedial Action | RL |
| 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 |
| Product Code | MMW |
| Date Received | 2011-05-20 |
| Catalog Number | 02J27-011 |
| Lot Number | 430090 |
| ID Number | 30-805070 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-05-20 |