MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-12-08 for PROBECHEK CONTROL SLIDES FOR PATHVYSION HER-2 DNA PROBE KIT 02J05-030 manufactured by Abbott Molecular, Inc..
[32979475]
An mdr 3005248192-2015-00020 follow-up report will be submitted after the elevated complaint investigation is finalized.
Patient Sequence No: 1, Text Type: N, H10
[32979476]
Customer reported receipt of (1) broken slide in (1) box of probechek control slides for the pathvysion her-2 dna probe kit. There was no evidence of external shipping damage to the box. No injury was reported. Because the probechek control slides contain human sourced components, if the issue of broken probechek slides were to recur, there is potential for exposure to infectious material that may cause or contribute to serious injury.
Patient Sequence No: 1, Text Type: D, B5
[37347776]
Summary of elevated complaint investigation (b)(4) for mdr 3005248192-2015-00020 follow-up report 1: investigation into this complaint included an evaluation of the quality data review (device history record (dhr) review and capa review), complaint history review, inspection of customer supplied images of damage, and inspection of the product (b)(4) retains from the same lots of material in question. Quality data review: device history record (dhr) review: no errors/issues were identified. Capa / non-conformance review: a search identified one capa involving proactive improvements to minimize the potential for broken slides; these improvements were completed by january 2014. 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; however, images were supplied to (b)(4) and attached to the individual complaint. The customer supplied images were reviewed to verify reported damage. The images did show damaged slides. There were no other reports of broken slides for the lots of material in question. The issue appears to be isolated, and no systemic deficiency has been identified based on review of the customer supplied images. Complaint history review: the search was completed to capture 12 months to account for one year. Two complaints originating in the u. S. Were identified complaints that were addressed in a previous unconfirmed complaint investigation. Product deficiency decision: based on the results of the investigation elements, a product or systematic deficiency has not been identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2015-00020 |
| MDR Report Key | 5275490 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-12-08 |
| Date of Report | 2016-02-02 |
| Date of Event | 2015-11-17 |
| Date Mfgr Received | 2016-01-13 |
| Date Added to Maude | 2015-12-08 |
| 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 PATHVYSION HER-2 DNA PROBE KIT |
| Generic Name | CONTROL SLIDES |
| Product Code | MVD |
| Date Received | 2015-12-08 |
| Catalog Number | 02J05-030 |
| Lot Number | 464026 |
| 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 EAST TOUHY AVENUE DES PLAINES IL 600183315 US 600183315 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-08 |