MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-13 for COULTER LH 750 HEMATOLOGY ANALYZER 6605632 manufactured by Beckman Coulter, Inc..
[1982258]
A customer contacted beckman coulter inc. (bci) stating that the coulter lh 750 analyzer mis-read the last digit of the sample id for a single patient sample in the automatic mode. Sample id (b)(4) was incorrectly read as (b)(4). The mis-read sample id was identified when the instrument generated a "no match" message. No erroneous results were reported out of the laboratory. The sample was rerun and it was read correctly. No death, serious injury, or change to patient treatment is associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[9009728]
A field service engineer (fse) was dispatched and reviewed the data with the customer. The fse replaced the laser bar code decoder card and the scanner ribbon cable. The fse ran a full cassette of specimens including the specimen that misread, all read without error. The root cause is unknown; however, the instrument's checksum was disabled. Per labeling, beckman coulter strongly recommends the use of bar-code checksums to provide automatic checks for read accuracy.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00409 |
| MDR Report Key | 2089072 |
| Report Source | 06 |
| Date Received | 2011-05-13 |
| Date of Report | 2011-04-13 |
| Date of Event | 2011-04-13 |
| Date Mfgr Received | 2011-04-13 |
| Device Manufacturer Date | 2003-02-01 |
| Date Added to Maude | 2012-03-28 |
| 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 | RL |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER LH 750 HEMATOLOGY ANALYZER |
| Generic Name | AUTOMATED DIFFERENTIAL CELL COUNTER |
| Product Code | LOQ |
| Date Received | 2011-05-13 |
| Model Number | LH 750 |
| Catalog Number | 6605632 |
| Lot Number | N/A |
| ID Number | SV 2D1 |
| 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 | 2011-05-13 |