MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-05-08 for PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT 02J27-011 manufactured by Abbott Molecular, Inc..
[5783131]
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 reported that slides in a probechek urovysion bladder kit control slides package were broken upon receipt. There was no report of injury. The probechek urovysion bladder kit control slides package insert indicates that these slides contain human sourced and/or potentially infectious components. If the issue of customers receiving broken probechek slides were to recur, it is possible that customers could cut themselves with a potentially infectious slide. Therefore, recurrence of this issue could potentially cause or contribute to serious injury or death.
Patient Sequence No: 1, Text Type: D, B5
[13379969]
Elevated complaint investigation (ecinv) (b)(4) is associated with mdr 3005248192-2015-00011. An mdr follow-up report will be submitted after the ecinv is finalized.
Patient Sequence No: 1, Text Type: N, H10
[34110098]
Summary of elevated complaint investigation (ecinv) (b)(4) for mdr 3005248192-2015-00011 follow-up report 1: the investigation included review of customer-supplied images, inspection of abbott molecular (am) retention samples from the lots in question, review of device history records, and review of capa and complaint report records. Related manufacturing and test records were reviewed, and no errors were identified. The manufacturing process is a manual process. Slides are 100% inspected at the manufacturing stage for specific issues including damage. Once placed into kits, the kits are sampled and inspected by quality control (qc). No issues were noted. In addition, a process is in place to minimize damage during shipment of slides from am. Review of the customer-supplied images did show damaged slides. Visual inspection of the qc retention samples from each lot in question (quantity: 3 slides per lot) showed no signs of damage. Other than the two complaints being addressed by this investigation (each complaint logged against a different lot of slides), there have been no other reports of broken slides in the past 12 months. One capa related to broken slides was identified. This capa was opened proactively as a result of management review to make improvements in three areas to minimize the potential for broken slides. The capa was resolved in (b)(6) 2014. (b)(4) which indicates that the issue may be seen with a frequency of "occasional. " no systemic product deficiency has been identified. Note1: the other complaint referenced in (b)(4) is addressed by mdr 3005248192-2015-00013. Note2: mdr 3005248192-2015-00011 follow-up report 1 contains a correction: initial reporter/ name and address information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2015-00011 |
| MDR Report Key | 4759733 |
| Report Source | 07 |
| Date Received | 2015-05-08 |
| Date of Report | 2015-04-24 |
| Date of Event | 2015-04-24 |
| Date Mfgr Received | 2015-06-03 |
| Date Added to Maude | 2015-06-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JEAN LEETE |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal | 600183315 |
| Manufacturer Phone | 2243617274 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018331 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 3315 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT |
| Generic Name | MICROSCOPIC CONTROL SLIDES USED IN FISH TESTING |
| Product Code | NSD |
| Date Received | 2015-05-08 |
| Catalog Number | 02J27-011 |
| Lot Number | 458959 |
| Device Availability | Y |
| Device Age | DA |
| 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 60018331 US 60018 3315 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-08 |