MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-05 for PROBECHEK MULTIVYSION CONTROL SLIDES 05J07-001 manufactured by Abbott Molecular, Inc..
[57252165]
Investigation is in process. Common device name includes general purpose reagent, product code: ppm. However, the product code ppm resulted in an error code (invalid code) by the fda e-submitter software in the device product code section. As a result product code ldt, reagent, general purpose, class i, pathology, (b)(4) - general purpose reagent was used in e-submitter. Probechek multivysion control slides (list number 05j07-001) is registered and listed as a general purpose reagent with a product code ppm, device class 1 and regulation number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[57252166]
(b)(4) distributor received 2 boxes of probechek multivysion control slides that had broken slides in it. There was no report of injury. The certificate of analysis for probechek multivysion control slides indicates these slides contain human sourced and/or potentially infectious components. If this event were to recur, it is possible customers could cut themselves with a potentially infectious slide.
Patient Sequence No: 1, Text Type: D, B5
[61047239]
Summary of complaint investigation for mdr 3005248192-2016-00006 follow-up report 1: investigation into this complaint included an evaluation of the quality data review, complaint history review, and retain sample evaluation. Quality data review : device history record / batch record review: no errors/ issues 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). No issues were noted during inspection. In addition, a process is in place to minimize damage during shipment of slides. Complaint history review: aside from the complaint currently being addressed by this investigation, three additional complaints reporting broken/damaged slides was reported in the last 12 months. (b)(4), which indicates that the issue may be seen with a frequency of "occasional. " retain and / or file sample evaluation: customer samples were not available for investigation. A visual inspection using am retain samples from the same lot of material in question was performed to determine if products had any visually identifiable damage. No damage was identified. Product deficiency decision: based on the results of the investigation elements, a product or systemic deficiency for probechek multivysion control slides has not been identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2016-00006 |
| MDR Report Key | 6001591 |
| Date Received | 2016-10-05 |
| Date of Report | 2016-11-15 |
| Date of Event | 2016-08-31 |
| Date Mfgr Received | 2016-10-20 |
| Date Added to Maude | 2016-10-05 |
| 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 | MRS SARAH PARKER |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal | 600183315 |
| Manufacturer Phone | 2243617355 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 E. 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 MULTIVYSION CONTROL SLIDES |
| Generic Name | GENERAL PURPOSE REAGENT, PRODUCT CODE: PPM |
| Product Code | LDT |
| Date Received | 2016-10-05 |
| Catalog Number | 05J07-001 |
| Lot Number | 469388 |
| Device Expiration Date | 2017-04-19 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 E. TOUHY AVE DES PLAINES IL 600183315 US 600183315 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-05 |