MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-11-29 for PROBECHEK MULTIVYSION CONTROL SLIDES 05J07-001 manufactured by Abbott Molecular, Inc..
[61089156]
Investigation is in process. Field d2 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, 864. 4010 - 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 864. 4010.
Patient Sequence No: 1, Text Type: N, H10
[61089157]
(b)(4) distributor received 1 box of probechek multivysion control slides that had broken slides in it. Additionally, it appeared that there was damage to the outer shipping package. There was no report of injury. The certificate of analysis for probecheck 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
[63128921]
Summary of the complaint investigation for mdr 3005248192-2016-00007. The investigation included review of quality data, inspection of abbott molecular (am) retention samples from the lots in question, and complaint history review. 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). No issues were noted during inspection. In addition, a process is in place to minimize damage during shipment of slides from am. A visual inspection using am retain samples from the same lots of material in question was performed to determine if products had any visually identifiable damage. No damage was identified. Aside from the complaint currently being addressed by this investigation, three additional complaints reporting broken/damaged slides was reported in the last 12 months. The current complaint rate for broken slides is 0. 05%, which indicates that the issue may be seen with a frequency of "occasional. " 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 | 3005248192-2016-00007 |
| MDR Report Key | 6133468 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-11-29 |
| Date of Report | 2016-12-14 |
| Date of Event | 2016-11-03 |
| Date Mfgr Received | 2016-12-07 |
| Device Manufacturer Date | 2016-09-29 |
| Date Added to Maude | 2016-11-29 |
| 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 | 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 AVE. |
| 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 | 2016-11-29 |
| Catalog Number | 05J07-001 |
| Lot Number | 472262 |
| Device Expiration Date | 2017-08-30 |
| 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 | 2016-11-29 |