MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-10-09 for UNICEL? DXC 600I SYNCHRON? ACCESS? CLINICAL SYSTEM A25640 manufactured by Beckman Coulter.
[20269661]
The customer reported discrepant creatine kinase-mb (ck-mb) patient results involving the unicel dxc 600i synchron access clinical system. One patient obtained an initial result of 0. 00 ng/ml. The customer also stated multiple ck-mb and myoglobin ind flags were obtained. The customer retested this patient? S sample on an alternate analyzer and obtained a higher result of ~10 ng/ml. This initial result was released from the laboratory. It is unknown how many patients were involved. The customer was uncertain if there was any impact or change to patient treatment. There has been no report of patient injury or change in patient treatment associated with this event. The customer examined the associated reagent packs and noted the packs had not been mixed. Quality control (qc) was out of specifications at the time of the event. Beckman coulter advised the customer to review all the results since the last acceptable quality control (qc) and reanalyze if required per laboratory procedure. A beckman coulter field service engineer (fse) was dispatched to assess the instrument.
Patient Sequence No: 1, Text Type: D, B5
[20492389]
The field service engineer (fse) replaced the transducer as the customer noted erratic level-detect system errors and resolved the issue. Service activity performed was verified to meet the specified requirements per established procedures. The instrument conformed to the manufacturer's published performance specifications and was returned to normal operation. In conclusion, a faulty transducer is the likely cause of the event. Beckman coulter continues to track and trend any incident related to this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2013-00836 |
| MDR Report Key | 3399151 |
| Report Source | 05,06 |
| Date Received | 2013-10-09 |
| Date of Report | 2013-09-13 |
| Date of Event | 2013-09-12 |
| Date Mfgr Received | 2013-09-13 |
| Device Manufacturer Date | 2007-03-30 |
| Date Added to Maude | 2014-01-10 |
| 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 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 600I SYNCHRON? ACCESS? CLINICAL SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2013-10-09 |
| Model Number | NA |
| Catalog Number | A25640 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-09 |