MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-06-29 for PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT 02J27-11 manufactured by Abbott Molecular, Inc..
[48511746]
Summary of elevated complaint investigation (ecinv) (b)(4): this is a summary of the investigation into the complaint registered for observing damaged slides upon receipt of probechek urovysion bladder cancer control slides kit, 3 slides-ivd, part# 30-805070 (list# 02j27-011) lot# 467381. Kit lot 467381 contains probechek urovysion control slides, part# 30-505070 lot# 466535. The investigation included review of device history records, inspection of abbott molecular (am) retention samples from the lots in question, 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 kit manufacturing stage for specific issues including damage. Once placed into kits, the kits are sampled and inspected by quality control (qc). During inspection, one minor physical defect (label defect) was identified, and that material was removed from inventory. No other issues were noted. In addition, a process is in place to minimize damage during shipment of slides from am. Aside from the complaint currently being addressed by this investigation, one additional complaint reporting broken/damaged slides was reported in the last 12 months. One capa related to broken slides was identified ((b)(4)). 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 january 2014. The current complaint rate for broken slides is (b)(4) (there were (b)(4) complaints for broken slides for (b)(4) units sold), which indicates that the issue may be seen with a frequency of "occasional. " no systemic product deficiency has been identified.
Patient Sequence No: 1, Text Type: N, H10
[48511747]
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 reported that the technician opened a box of urovysion control slides and discovered broken slides. The customer reported that personal protective equipment was utilized and there were no injuries. 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
[74515359]
It was identified on april 20, 2017, that upon submission of the initial report, mfr contact office - name/address/phone number had been left blank. This follow up is being submitted to provide the following information. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2016-00004 |
| MDR Report Key | 5760643 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-06-29 |
| Date of Report | 2017-04-27 |
| Date of Event | 2016-05-31 |
| Date Mfgr Received | 2017-04-20 |
| Date Added to Maude | 2016-06-29 |
| 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 | KATHLEEN ZENG |
| Manufacturer Street | 1300 EAST TOUHY AVENUE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal | 600183315 |
| Manufacturer Phone | 2243617212 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600183315 |
| Single Use | 3 |
| 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 | 2016-06-29 |
| Catalog Number | 02J27-11 |
| Lot Number | 467381 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 EAST TOUHY AVENUE DES PLAINES IL 600183315 US 600183315 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-29 |