MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-15 for VP 2000 PROCESSOR 02J11-01 manufactured by Abbott Molecular, Inc..
[43637850]
An mdr follow-up report will be submitted after the elevated complaint investigation concludes.
Patient Sequence No: 1, Text Type: N, H10
[43637851]
The abbott vp 2000 processor is a device designed to automate and standardize slide specimen processing and routine slide staining for the laboratory. Customer reported that when slides were removed from the drying station on the vp2000 instrument the slide rack was noticeably hotter than usual. There was no report of injury. The abbott field service engineer (fse) cleaned off signs of drip/dry buffer on and around the dryer assembly thermistor. Temperature verifications and checks were within manufacturer specifications. The fse restored the vp2000 to its operational condition. An abbott elevated complaint investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[47541671]
Elevated complaint investigation (b)(4) for mdr 3005248192-2016-00002 follow-up report 1 included an existing data review, quality data review (capa/nonconformance review), product/system/instrument evaluation, and complaint history review. The information in this complaint identified that dryer assembly (part 30-144163ro) failures did occur however the overall product design requirements continue to be met. The overall product performed as designed, per safety standard iec 61010-1, and continues to perform as expected when this failure mode occurs, as there is no evidence that the single fault condition temperature exceeded 105? C on any touchable surface. Based on the investigation results, no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
[74820984]
It was identified on april 20, 2017, that upon submission of the initial report, date of this report incorrectly stated 03/17/2016 when it should have stated 04/15/2016.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2016-00002 |
| MDR Report Key | 5583428 |
| Date Received | 2016-04-15 |
| Date of Report | 2017-04-27 |
| Date of Event | 2016-03-17 |
| Date Mfgr Received | 2017-04-20 |
| Date Added to Maude | 2016-04-15 |
| 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 | VP 2000 PROCESSOR |
| Generic Name | AUTOMATED SLIDE STAINER |
| Product Code | KEY |
| Date Received | 2016-04-15 |
| Catalog Number | 02J11-01 |
| 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 | 2016-04-15 |