MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-02 for SYNCHRON CX3 DELTA 467501 manufactured by Beckman Coulter Inc..
[1854770]
A customer contacted beckman coulter inc. , (bci) and stated that the cx3 system originally generated a suppressed creatinine result. The customer repeated the test and a false low result of 0. 6 mg/dl was generated. This result did not match with delta check. The customer then confirmed the test on another analyzer which yielded a believable result of 2. 87 mg/dl. The customer provided additional data which includes the original and the amended results. It appears that the false low creatinine result was reported out of the lab. On (b)(6) 2011, the customer sent data which included additional patient results that are different from the results reported by the customer on the date of contact. Bci called the customer multiple times to request for clarification. Customer did not call back. False result was not reported outside of the lab for one sample that was reported by the customer during that date of contact. However, based on the additional data that the customer sent, the customer included the amended creatinine result from another patient sample. Unknown if treatment was initiated or withheld based on the result that the customer reviewed and amended.
Patient Sequence No: 1, Text Type: D, B5
[9028513]
Qc was run prior to the event and the results were within established ranges. The customer performed calibration after the event and calibration failed. The customer performed troubleshooting and recalibrated cre3 with passing results. A field service engineer (fse) was dispatched: the fse removed the creatinine module, disassembled and cleaned the cup. The fse replaced the stir bar and reassembled the module. The fse performed calibration and qc and the results met specifications. Root cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-01128 |
| MDR Report Key | 2073778 |
| Report Source | 06 |
| Date Received | 2011-05-02 |
| Date of Report | 2011-04-01 |
| Date of Event | 2011-04-01 |
| Date Mfgr Received | 2011-04-01 |
| Device Manufacturer Date | 2005-10-25 |
| Date Added to Maude | 2012-02-09 |
| 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 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 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON CX3 DELTA |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJF |
| Date Received | 2011-05-02 |
| Model Number | CX3 DELTA |
| Catalog Number | 467501 |
| ID Number | SV 4.9 |
| 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 | 2011-05-02 |