MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-08-10 for PROBECHECK ALK POSITIVE CONTROL SLIDES 06N38-10 manufactured by Abbott Molecular, Inc..
[51874652]
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Patient Sequence No: 1, Text Type: N, H10
[51874653]
The probechek alk negative control slides are intended for use as an assay control for appropriate hybridization conditions during routine use of the vysis alk break apart fish probe kit (list no. (b)(4). The probechek alk negative control slides should be assayed in conjunction with the user's specimen slides according to the package insert for the vysis alk break fish probe kit. A customer reported that 2 out of 5 probechek alk negative control slides were received broken. There was no report of injury. The probecheck alk negative control slide package insert indicates these slides contain human sourced and/or potentialy 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
[53463821]
Corrected name of product from "probechek alk negative control slides" to "probechek alk positive control slides". Summary of complaint investigation for mdr 3005248192-2016 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. Product under investigation met quality specifications at the time of release. 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. Complaint history review: products are individually qualified by lot. This is the first complaint for the lot of material in question. Product/system/instrument evaluation - retain and / or file sample evaluation: customer samples were not available for investigation: retain material was inspected for any visible signs of damage to the slide case (outer packaging) or to the slides themselves. No physical damage was identified. Product deficiency decision: based on the results of the investigation elements, a product or systemic deficiency for probechek alk positive control slides has not been identified.
Patient Sequence No: 1, Text Type: N, H10
[53463822]
The probechek alk positive control slides are intended for use as an assay control for appropriate hybridization conditions during routine use of the vysis alk break apart fish probe kit (list no. 06n38). The probechek alk positive control slides should be assayed in conjunction with the user's specimen slides according to the package insert for the vysis alk break fish probe kit. A customer reported that 2 out of 5 probechek alk positive control slides were received broken. There was no report of injury. The probecheck alk positive control slide package insert 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 | 3005248192-2016-00005 |
| MDR Report Key | 5864091 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-08-10 |
| Date of Report | 2016-08-29 |
| Date of Event | 2016-07-12 |
| Date Mfgr Received | 2016-08-10 |
| Date Added to Maude | 2016-08-10 |
| 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 | PROBECHECK ALK POSITIVE CONTROL SLIDES |
| Generic Name | MICROSCOPIC CONTROL SLIDES USED IN FISH TESTING |
| Product Code | OWE |
| Date Received | 2016-08-10 |
| Catalog Number | 06N38-10 |
| Lot Number | 465684 |
| 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 | 2016-08-10 |