MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-05-29 for UNICEL? DXC 800 SYNCHRON? SYSTEM A11812 manufactured by Beckman Coulter.
[18814152]
The customer reported obtaining an erroneously high actm (acetaminophen) result for one (1) patient involving the unicel dxc 800 synchron system and the patient was treated based on the erroneous result. The customer had initially called beckman coulter on (b)(6) 2013 to report an instrument-generated "cuvette not dry before reagent dispense" error message. The customer stated that the error messaged was noted before maintenance was performed and the customer continued to see the message after maintenance was completed; it is unknown of what maintenance was performed by the customer. Cts (customer technical support) had the customer perform all routine troubleshooting steps for this error message but the customer did not call back. On (b)(6) 2013, the supervisor notified beckman coulter of erroneously high actm results which were generated twice for one patient over the weekend. Results of >600 ug/ml were allegedly generated twice on the same sample and results were reported out of the laboratory. It is unknown how the customer obtained a result of >600 ug/ml since the analytical range for actm is 10-300 ug/ml. The patient was treated in the e. R. (emergency room) and resulted in a rash or hives reaction. It is unknown of what treatment was given to the patient but the customer confirmed no other problems were noted with the patient and there was no treatment given to reverse the effect. Beckman coulter contacted the customer numerous times to request for patient data but was not provided by the customer although promised. The supervisor admitted that the medical technologists continued to run the instrument over the weekend after speaking to beckman coulter regarding the "cuvette not dry before reagent dispense" error message on (b)(6) 2013. The supervisor stated that the instrument was still generating the "cuvette not dry before reagent dispense" error message and other assays on the cc (cartridge chemistry) side were failing with absorbance low error messages and suppressed results. In addition, the customer found leaking reagent probes on the cc side of the instrument but continued to run the instrument.
Patient Sequence No: 1, Text Type: D, B5
[19061202]
A beckman coulter fse (field service engineer) was dispatched on (b)(4) 2013 and noted loose reagent probe fittings but tightening the fittings did not resolve the cuvette error message. The fse replaced the reagent wash collars as a precaution. The fse stated that the cuvettes and carousel area needed to be died out to eliminate the error message. After the repairs were completed, the customer reran the original tube twice, obtained results of <10 ug/ml for actm and issued amended reports out of the laboratory. The customer does not have any other information regarding the patient but noted there were no other samples for this patient was obtained and sent to the customer's laboratory as of (b)(4) 2013. The customer has not been contacted by the attending physician. The customer reran other samples with absorbance low messages and obtained acceptable results. Results: failure mode is attributed to customer use error. The instrument generated error messages to alert the customer of an instrument problem but the customer ignored the instrument-generated error messages and fluid which was left within and around the cuvette carousel area and continued to run the instrument after acknowledging the issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2013-00352 |
| MDR Report Key | 3131628 |
| Report Source | 05,06 |
| Date Received | 2013-05-29 |
| Date of Report | 2013-04-29 |
| Date of Event | 2013-04-27 |
| Date Mfgr Received | 2013-04-29 |
| Device Manufacturer Date | 2008-05-16 |
| Date Added to Maude | 2013-05-29 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER |
| 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 | UNICEL? DXC 800 SYNCHRON? SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | LDP |
| Date Received | 2013-05-29 |
| Model Number | NA |
| Catalog Number | A11812 |
| Lot Number | NA |
| ID Number | SW VERSION 4.92 |
| 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 | 1. Other | 2013-05-29 |