MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-10 for COULTER LH 750 ANALYZER 6605632 manufactured by Beckman Coulter, Inc..
[1956335]
A customer contacted beckman coulter inc. (bci) stating that the coulter lh 750 analyzer generated an erroneously low platelet (plt) result of 62 on a single patient sample. The result was reported out (auto-validated) of the laboratory as there were no instrument flags. The physician questioned the results because higher platelet counts were expected based on the patient's previous history (plt = 328 and 331). Customer indicated that the specimen was not checked for clots and that a manual platelet count or scan was not performed on the patient specimen. The patient was redrawn at another facility and the plt results were higher (plt = 308), as expected, which was considered to be the correct result. There was no death, injury, or affect to patient treatment reported for this event.
Patient Sequence No: 1, Text Type: D, B5
[9091621]
The sample was collected in bd vacutainer 5 ml tube and processed the same day. The controls were run before and after the event and recovered within range. The start-up results were acceptable as well. It is unknown whether service was dispatched for this event. Root cause is unknown for this event. Bci product labeling states: misleading results can occur if specimens contain clots. Always use good laboratory practices for inspecting specimens for clots and verifying results. Known interfering substances for platelets include: giant platelets, platelet clumps, white cell fragments, electronic noise, very small red cells, and red cell fragments.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00125 |
| MDR Report Key | 2015326 |
| Report Source | 06 |
| Date Received | 2011-03-10 |
| Date of Report | 2011-02-08 |
| Date of Event | 2011-01-28 |
| Date Mfgr Received | 2011-02-08 |
| Device Manufacturer Date | 2010-03-01 |
| 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 |
| 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 | 2011-03-10 |
| Model Number | LH 750 |
| Catalog Number | 6605632 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-03-10 |