MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-17 for COULTER LH 750 ANALYZER 6605632 manufactured by Beckman Coulter, Inc..
[15506289]
A customer contacted beckman coulter inc. (bci) stating that erroneous results were obtained for a patient sample after the complete blood count (cbc) lyse was mistakenly replaced with the clenz reagent on the coulter lh 750 analyzer. The erroneous results were reported out of the laboratory. The customer identified that the reagents were switched because they were having an h/h failure and during the troubleshooting process, the customer technical support (cts) had the customer check the cbc lyse reagent. The sample was rerun on an alternate instrument and results from this instrument were sent out as a corrected report. There was no death, injury, or change to patient treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[15650989]
The sample was collected in 5ml bd tube and stored at room temperature. The sample was 20 minutes old before processing. Per the customer, the controls were not run after the event because service had to flush out the cbc lyse reservoir. The customer replaced clenz with correct lyse reagent once they discovered what had occurred. A field service engineer (fse) reviewed customer control recovery, performed start-up, and ran controls. The fse verified repair per established procedures. Results met published performance specifications. The root cause was operator error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00147 |
| MDR Report Key | 2021272 |
| Report Source | 06 |
| Date Received | 2011-03-17 |
| Date of Report | 2011-02-14 |
| Date of Event | 2011-02-14 |
| Date Mfgr Received | 2011-02-14 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2012-02-15 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER LH 750 ANALYZER |
| Generic Name | AUTOMATED DIFFERENTIAL CELL COUNTER |
| Product Code | LOQ |
| Date Received | 2011-03-17 |
| Model Number | LH 750 |
| Catalog Number | 6605632 |
| Lot Number | N/A |
| 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 AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-17 |