MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-30 for UNICEL? DXL 600 ACCESS? IMMUNOASSAY SYSTEM A71461 manufactured by Beckman Coulter Inc..
[2958563]
A customer contacted beckman coulter inc. , (bec) and reported multiple occurrences of erroneous and/or imprecise creatine kinase-mb (ck-mb) results on two patient samples tested on unicel dxl 600 access immunoassay system. This report is to document ckmb results for patient # (b)(6). The customer stated the results for this patient were obtained from serial collections (four separate samples were collected). The ck-mb results exhibited imprecision outside specification, with some results within the normal reference range and some above. The customer's qc was within the laboratory's established limits before the event. No other ck-mb results or other assays were in question. The customer stated no erroneous results were reported outside the laboratory. The customer did not report an effect to patient or user attributed to or connected to this event.
Patient Sequence No: 1, Text Type: D, B5
[10260835]
The laboratory utilizes 5 ml bd lithium heparin plasma separator tubes with gel for ck-mb sample collections. The customer centrifuges ck-mb samples for 3 minutes at ambient temperature in a stat span express 4 centrifuge. The customer declined to provide centrifugation speed. Per customer, the sample was processed within one hour of collection. The customer provided system check data from (b)(6) 2012; all system check parameters were passing within specifications. No event log messages were generated in connection with this event. A bec field service engineer (fse) was dispatched to the customer's site. The fse adjusted pipettor temperatures and verified pipettor alignments. The fse performed a system check and high sensitivity system check; both system checks passed for all parameters within specification. The fse verified that ck-mb precision was within specification and verified that the customer's qc was within the laboratory's established limits. The instrument was verified as performing to published performance specifications. A cause for this event could not be determined with the information supplied.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-01942 |
| MDR Report Key | 2853433 |
| Report Source | 05,06 |
| Date Received | 2012-11-30 |
| Date of Report | 2012-11-07 |
| Date of Event | 2012-11-07 |
| Date Mfgr Received | 2012-11-07 |
| Device Manufacturer Date | 2012-07-23 |
| Date Added to Maude | 2013-03-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXL 600 ACCESS? IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2012-11-30 |
| Model Number | NA |
| Catalog Number | A71461 |
| Lot Number | NA |
| ID Number | SW VERSION 4.4 |
| 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 | 2012-11-30 |