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..
[1918517]
A customer contacted beckman coulter inc. (bci) stating that the coulter lh 750 analyzer generated erratic differential results on twenty-six (26) patient specimens. Of twenty-six (26) specimens twelve (12) had instrument generated r (review result) flags on the differential parameters. The customer stated that the laboratory protocol is to run the specimens in batches of fifty (50) specimens, preceded and followed by a control. The operator noticed that the control recovered outside qc limits and aborted the batch run after twenty six (26) specimens had been completed. No erroneous results were reported outside the laboratory. The custom reran the specimens on an alternate instrument and verified the results before reporting. There was no death, injury, or change to patient treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[8832584]
The specimens were collected in 5 ml venoject vacutainer tubes and transported refrigerated and stored at room temperature. Controls were run before and after the incident and the error was discovered because the batch control recovered outside qc limits. The instrument is currently within qc specifications with respect to controls (accuracy) and reproducibility (precision). A field service engineer (fse) was dispatched and replaced the ls pre-amp assembly and adjusted the gain, which was the root cause of this event. The fse also verified the instruments operation. Beckman coulter inc. Does not claim to identify every abnormality in all samples. Beckman coulter inc. Suggests using all available flagging options to optimize the sensitivity of instrument results based on your patient population. All flagging options include reference ranges (h/l), action and critical limits, definitive flags, suspect flags, parameter codes, delta checks, decision rules and system alarms. Beckman coulter inc. Recommends avoiding the use of single messages or outputs to summarize specimen results or patient conditions. There may be situations where the presence of rare events may fail to trigger a suspect message.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00148 |
| MDR Report Key | 2021273 |
| Report Source | 06 |
| Date Received | 2011-03-17 |
| Date of Report | 2011-02-14 |
| Date of Event | 2011-02-11 |
| Date Mfgr Received | 2011-02-14 |
| Device Manufacturer Date | 2006-06-01 |
| 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 | MA |
| 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 |