MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-26 for COULTER LH 750 ANALYZER 6605632 manufactured by Beckman Coulter Inc..
[1920139]
A customer contacted beckman coulter inc. (bci) stating that the coulter lh 750 analyzer mis-read three (3) bar code labels, with each generating a no match message. Upon rerun the label was read correctly. No erroneous results were reported outside the laboratory. There was no death, injury or change to patient treatment as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9159533]
The customer does not use check digits to verify bar codes. A field service engineer (fse) was dispatched on (b)(4) 2011 and cleaned and tested the barcode reader. The fse reran the samples and some labels read correctly and some incorrectly or were not read by the system (no read message). Per the fse, the labels had gaps in the bars when viewed under a magnifying glass. The fse suspects this issue may be due to the bar code labels the customer uses. The fse informed the technicians to verify every sample id on the tube with the result printout sample id and names. Per product labeling, risk of misidentification. Use of poor quality, dirty, improperly placed or damaged bar-code labels could keep the instrument from reading the bar-code labels. Ensure the bar-code labels are undamaged. Ensure the bar-code labels conform to the specifications provided in chapter 4 of the reference manual. Beckman coulter strongly recommends the use of bar-code checksums to provide automatic checks for read accuracy. Label specifications state: no spots or voids; no ink smearing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00189 |
| MDR Report Key | 2030094 |
| Report Source | 06 |
| Date Received | 2011-03-26 |
| Date of Report | 2011-02-23 |
| Date of Event | 2011-02-23 |
| Date Mfgr Received | 2011-02-23 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2012-02-16 |
| 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 | 2011-03-26 |
| 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 | 2011-03-26 |