MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-02-23 for COULTER LH 750 ANALYZER 6605632 manufactured by Beckman Coulter, Inc..
[1844964]
A customer contacted beckman coulter inc. (bci) stating that the coulter lh 750 analyzer generated intermittent erroneously high red blood count (rbc), hematocrit (hct), mean cell volume (mcv), and platelet (plt) results on a patient specimen without instrument generated flags. The customer also indicated that this only occurs intermittently after the instrument generates a fatal error and the instrument is reset. The result was flagged with an operator-definable h&h check failure flag. The erroneous results were reported out of the laboratory. However, the nurse questioned the high platelet result and the lab reviewed the patient results. Upon review the operator noticed that the hemoglobin (hgb) and hct did not match. The patient was redrawn on the same instrument and recovered lower rbc, hct, mcv and plt results which the customer considers correct. There was no death, injury, or change to patient treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[9096792]
The specimen was collected in a 3-4 ml bd vacutainer tube and sampled within 2 hours of collection and stored at room temperature. Controls were run prior to the event and all controls recovered within assay limits. Per the customer, the instrument is currently performing within qc specification with respect to controls (accuracy) and reproducibility (precision). A field service engineer (fse) was dispatched on (b)(4) 2011 and found the guide rods on the needle cap pierce module to be worn down. The fse re-visited on (b)(4) 2011 for this event. The fse performed troubleshooting and replaced multiple hardware parts and performed all necessary alignments. Fse also performed multiple system checks and performance tests and ran qc. The fse re-visited again on (b)(4) 2011 and determined that the instrument's baths are not draining when the instrument is reset. The fse discovered that the switch was on fast reset and was then changed to normal reset. The root cause for erroneous high rbc, hct, mcv and platelets is due to parts replaced and instrument servicing performed subsequent to this cf event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00099 |
| MDR Report Key | 1999702 |
| Report Source | 06 |
| Date Received | 2011-02-23 |
| Date of Report | 2011-01-24 |
| Date of Event | 2011-01-23 |
| Date Mfgr Received | 2011-01-24 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2012-02-08 |
| 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 | 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 | RP |
| 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 | 2011-02-23 |
| 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 | 2011-02-23 |