MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-08 for LDLD (LDL CHOLESTEROL) REAGENT 969706 manufactured by Beckman Coulter, Inc..
[17103103]
The customer contacted beckman coulter, inc. (bec) to report a discrepancy between a direct low density lipoprotein (ldld) result and the calculated low density lipoprotein (ldl) result for the same patient sample. The ldld analysis was performed on their unicel dxc 600 pro synchron chemistry analyzer. The patient results were reported out of the laboratory. The ordering physician questioned the discrepancy between the ldld result and the calculated ldl result. The physician did not alter patient treatment due to the discrepant ldl results. The patient sample in question was also analyzed for cholesterol (chol), triglycerides (tg), and high density lipoprotein (hdl). Other patient samples were analyzed at the same time as the patient sample in question. No discrepancies between ldld and calculated ldl were observed for the other patient samples. The customer performed repeat tg analyses using various dilutions of the patient sample to rule out the presence of an interfering substance. The results of the diluted tg analyses were in agreement with the original undiluted tg result. The customer had sent the patient sample to an independent reference laboratory for analysis. The results for ldld and calculated ldl were in agreement. At bec's request, the customer sent the patient sample to bec for additional analysis. The analysis performed by bec confirmed the original results generated by the customer. Furthermore, the bec analysis determined that an interfering substance(s) is present in the patient's sample which is impacting the performance of the hdl and ldld assays (no interference was observed in the chol assay). In addition, the patient sample exhibited a high tg concentration. The combination of an interference in the hdl assay along with the high tg concentration could cause the discrepancy observed in the calculated ldl result (using the friedewald equation). Based on the analysis performed, bec believes the ldld result is closer to the actual concentration of ldl in the patient's sample versus the calculated ldl result. A root cause has not yet been determined for this event. There were no other patient samples exhibiting discrepancies between ldld and calculated ldl reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
[17185629]
The root cause of this event may be attributable to an interfering substance(s) in the patient sample. No other patient samples analyzed at the time exhibited discrepant results. Service was not dispatched to the customer's site for this event. At bec's request, the customer sent the patient sample in question to bec for analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-04010 |
| MDR Report Key | 2238656 |
| Report Source | 05,06 |
| Date Received | 2011-09-08 |
| Date of Report | 2011-07-12 |
| Date of Event | 2011-07-12 |
| Date Mfgr Received | 2011-07-12 |
| Date Added to Maude | 2012-05-25 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LDLD (LDL CHOLESTEROL) REAGENT |
| Generic Name | LOW DENSITY LIPOPROTEIN TEST SYSTEM |
| Product Code | MRR |
| Date Received | 2011-09-08 |
| Catalog Number | 969706 |
| Lot Number | NOT PROVIDED |
| 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 | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-08 |