MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-01 for COULTER GEN-S SYSTEM 6605381 manufactured by Beckman Coulter, Inc..
[2321083]
The customer had contacted beckman coulter, inc (bec) to report that a barcode was misread on their coulter gen-s system. The pt sample identification numbers matched with the numbers in the customer's lis (laboratory info system). Pt sample results were released from the laboratory. There was no impact to pt sample results or pt treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[9570952]
The two impacted pt sample identification numbers misread the number "3" as "$". A field service engineer (fse) was dispatched to the customer's site. The fse verified the bar code read rate and performed service to the instrument. The fse observed that the bar code labels being used by the customer were of poor quality. It was determined that the checksum digit was disabled. Product labeling contains the following recommendation regarding the checksum algorithm: "beckman coulter, inc strongly recommends the use of bar-code checksums to provide automatic checks for read accuracy. " the root cause for this event is attributed to not using the checksum algorithm and not using bar code labels of sufficient quality. This reportable event was identified during a retrospective review conducted between 01/01/2008 and 10/23/2010 of complaints for add'l reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-02470 |
| MDR Report Key | 2356570 |
| Report Source | 05,06 |
| Date Received | 2011-12-01 |
| Date of Report | 2008-12-30 |
| Date of Event | 2008-12-28 |
| Date Mfgr Received | 2008-12-30 |
| Device Manufacturer Date | 1997-04-01 |
| Date Added to Maude | 2012-07-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVE. |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER GEN-S SYSTEM |
| Product Code | GKL |
| Date Received | 2011-12-01 |
| Model Number | NA |
| Catalog Number | 6605381 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVE. MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-01 |