MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-05-11 for PROBECHEK MULTIVYSION CONTROL SLIDES 05J07-01 manufactured by Abbott Molecular, Inc..
[75008310]
Field 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 (b)(4)) is registered and listed as a general purpose reagent with a product code ppm, device class 1 and regulation number (b)(4). Summary of complaint investigation: investigation into this complaint included an evaluation of the quality data review, complaint history review, review of customer images and retain sample evaluation. Quality data review: device history record / batch record review no errors/issues were identified. The products under investigation met quality specifications at the time of release. A process review indicated slides are inspected at regular intervals for damage in the manufacturing process and that slides are packed and shipped sufficiently to minimize damage. Retain / file sample evaluation: 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. Return sample evaluation: the customer's samples were not available for investigation. Note that broken slides would not be requested for return in order to minimize potential harm to the handler. The customer provided images. Review of the images indicated that 1 of 5 slides was broken (broken slide was nearest to front label position). Complaint history review: five complaints reporting broken/damaged slides were identified for the past year. Current complaint rate for broken slides is 0. 06%, which indicates that the issue may be seen with a frequency of "occasional". Product deficiency decision: based on the results of the investigation elements, a product or systemic deficiency for probechek multivysion control slides list# (b)(4) lot# 473332 has not been identified.
Patient Sequence No: 1, Text Type: N, H10
[75008311]
(b)(4) distributor received slides from abbott molecular, they found that 1 box of the multivysion control slide was damaged. Based on the images provided, at least one slide appeared to be broken. 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
| Report Number | 3005248192-2017-00002 |
| MDR Report Key | 6560231 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-05-11 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-04-20 |
| Date Mfgr Received | 2017-04-20 |
| Device Manufacturer Date | 2016-11-30 |
| Date Added to Maude | 2017-05-11 |
| 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 EAST TOUHY AVENUE. |
| 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 | 2017-05-11 |
| Catalog Number | 05J07-01 |
| Lot Number | 473332 |
| Device Expiration Date | 2017-11-07 |
| Device Availability | Y |
| 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 | 2017-05-11 |