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 PATHVYSION HER-2/NEU CUT-OFF CONTROL SLIDES 02J04-030 (30-805042) manufactured by Abbott Molecular, Inc..
[1590591]
The probechek her-2/neu control slides are prepared from cultured human cell lines. The cells are harvested, fixed in suspension medium, paraffin-embedded, and applied to glass microscope slides. The procedures used to harvest the cells and prepare the slides are optimized for production of slides for interphase fish. Customer received one box of the probechek slides open and some of the slides had slid out of box during shipment and cracked. There was no damage to the outside of shipping carton observed; only the slides were damaged. Customer discarded affected box of slides. Per probechek, control slides for fluorescence in situ hybridization (fish)* using pathvysion, her-2 dna probe kit (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 injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8763617]
Inspection from qc retention sample from the lot in question identified no damaged (cracked/broken) slides. 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
[10298216]
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 | 3005248192-2010-00004 |
| MDR Report Key | 1828145 |
| Report Source | 07 |
| Date Received | 2010-09-08 |
| Date of Report | 2010-06-08 |
| Date of Event | 2010-06-08 |
| Date Mfgr Received | 2012-10-19 |
| Device Manufacturer Date | 2010-04-19 |
| 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 PATHVYSION HER-2/NEU CUT-OFF CONTROL SLIDES |
| Generic Name | MICROSCOPIC CONTROL SLIDES USED IN FISH TESTING |
| Product Code | MVD |
| Date Received | 2010-09-08 |
| Catalog Number | 02J04-030 (30-805042) |
| Lot Number | 424694 |
| Device Expiration Date | 2011-03-06 |
| Operator | OTHER |
| Device Availability | N |
| 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 |