MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-15 for UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter, Inc..
[22128313]
The customer reported elevated creatine kinase-mb (ck-mb) results for one patient involving unicel dxi 800 access immunoassay system. This is report number one of six referencing system (b)(4). Two previous samples from the same patient produced normal ck-mb results. A third sample was collected but did not produce ck-mb results. The elevated results were released out of the laboratory. There was no report of patient injury or change in patient treatment associated with this event. The field service engineer (fse) went to the facility and assessed the unit.
Patient Sequence No: 1, Text Type: D, B5
[22257407]
The field service engineer (fse) serviced the unit at the facility on (b)(4) 2008. Prior to the event, the fse was at the facility and completed a preventive maintenance (pm). The fse performed and completed system check. The fse performed and completed twenty-replicate precision tests for creatine kinase-mb (ck-mb) and troponin. All results were within expectations and conformed to the manufacturer's established specifications. Quality control (qc) was performed approximately 23 hours prior to the event and resulted within range. A system check completed on (b)(6) 2008 conformed to specifications. The customer stated the five replicate precision test of the patient's sample was performed following the system clean routine. A review of archive data, collected on (b)(6) 2008, showed a daily system cleaning had not been performed. The sample was collected into a bd plasma lithium heparin plastic tube with gel. The customer could not provide specifics details regarding sample collection, only that the sample was likely collected in by the nursing staff and was a full draw. The re-centrifugation of the primary tube occurred in the primary tube and not an aliquot. Re-centrifugation of the primary tube can lead to cellular debris. The assay manual does provide guidelines to ensure residual fibrin and cellular matter have been removed prior to analysis and to follow recommendations for centrifugation of the tube manufacturer. Product labeling: the access ck-mb results should be interpreted in light of the total clinical presentation of the patient, including: symptoms, clinical history, data from additional tests and other appropriate information. This reportable event was identified during a retrospective review of product complaints conducted from (b)(4) 2008 through (b)(4) 2010 for additional reportable events. This medwatch report is related to mdrs: 2122870-2011-02325, 02326, 02327, 02328, 02329.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-02286 |
| MDR Report Key | 2169764 |
| Report Source | 05,06 |
| Date Received | 2011-07-15 |
| Date of Report | 2008-03-19 |
| Date of Event | 2008-03-19 |
| Date Mfgr Received | 2008-03-19 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2011-10-05 |
| 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 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 | 1000 LAKE HAZELTINE DR. |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM |
| Product Code | JHS |
| Date Received | 2011-07-15 |
| Model Number | NA |
| Catalog Number | 973100 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DR. CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-15 |