MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-10-14 for COULTER GEN-S SYSTEM 6605381 manufactured by Beckman Coulter, Inc..
[2339742]
The customer contacted beckman coulter, inc (bec) to report that the presence of blasts in a pt sample was erroneously not flagged when analyzed on their coulter gen-s system. The erroneous pt sample results were reported out of the lab. The pt's treatment was delayed because the initial results were not flagged for the presence of blasts. A manual differential was not performed on the initial pt sample and the presence of blasts was not reported until hours later. Several samples from the pt were drawn and assayed over a period of several days on two different analyzers in the lab. Only this medwatch report and medwatch report# 1061932-2011-01659 are being classified as adverse events since the presence of blasts was known by the time the subsequent assays were performed (i. E pt treatment was no longer delayed and had commenced by then). The customer reported that quality control (qc) samples were assayed prior to the event and all results had recovered within the lab's established ranges.
Patient Sequence No: 1, Text Type: D, B5
[9425653]
Beckman coulter, inc does not claim to identify every abnormality in all samples. Beckman coulter, inc suggests using all available flagging to optimize the sensitivity of the instrument results. There may be situations where the presence of the rare event may fail to trigger a suspect message. A field service engineer (fse) was dispatched to the customer's site. The fse measured offset voltages for both differentials and reticulocytes; both channels were within acceptable limits. The fse checked the latron primer and control and adjusted the position of the flowcell to reduce cvs on the scatter to less than 4. 0. The fse performed a sizing check on the red blood cell (rbc) and white blood cell (wbc) apertures. The fse adjusted the voltages/current to bring wbc values back to 94. 3 fl. The fse ran samples obtained from a reference lab, measured the volume channel for noise, and adjusted the volume of slyse in the diff mix chamber. The fse reassayed the samples and adjusted noise levels back down to approx 100 mv ac. The fse increased the diff pressure. The fse verified the repairs per established procedures. All results met published performance specifications. This reportable event was identified during a retrospective review conducted between (b)(4) 2008 and (b)(4) 2010 of complaints for add'l reportable events. This mdr represents event 1 of 6 reported by the customer. This mdr is related to the following mdrs that have been reported: 1061932-2011-01659, 01660, 01661, 01662, 01663.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01658 |
| MDR Report Key | 2318566 |
| Report Source | 01,05,06 |
| Date Received | 2011-10-14 |
| Date of Report | 2009-08-20 |
| Date of Event | 2009-08-14 |
| Date Mfgr Received | 2009-08-20 |
| Device Manufacturer Date | 2001-10-01 |
| Date Added to Maude | 2011-11-03 |
| 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 | 2011-10-14 |
| Model Number | NA |
| Catalog Number | 6605381 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Other | 2011-10-14 |