MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-06 for BECKMAN COULTER DXC 700 AU DXC 700 AU-10E B86444 manufactured by Beckman Coulter.
[101730240]
A beckman coulter application specialist evaluated the instrument. The application specialist identified that the dxc 700 au was configured to perform automatic undiluted repeats of high ferritin results. This was incompatible with settings on the lab's middleware system (bec remisol platform), which was configured to reflex order a dilution of high samples. The middleware was configured to apply the dilution factor to the result uploaded from the analyzer. When the analyzer sent the (undiluted) result, the middleware multiplied the result by the dilution factor, resulting in an erroneously high ferritin. The application specialist disabled the repeat setting at the dxc 700 au and evaluated all parameters for incompatible repeat settings. The system is now working as desired.
Patient Sequence No: 1, Text Type: N, H10
[101730241]
The beckman coulter dxc 700 au generated an erroneously high ferritin result of >1350 ng/ml. The result was reported out of the lab. The customer stated that the patient received an unnecessary needle biopsy. The customer stated the decision to perform a biopsy was "partly a consequence" of the high ferritin result. The customer has not reported to bec of any harm to the patient in relation to the biopsy. The customer stated that quality control prior to and after the event was within laboratory established ranges. No data was provided from the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612296-2018-00025 |
| MDR Report Key | 7318549 |
| Date Received | 2018-03-06 |
| Date of Report | 2018-02-08 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-02-08 |
| Device Manufacturer Date | 2017-05-01 |
| Date Added to Maude | 2018-03-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD. M/S E1.SE.01 |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | BECKMAN COULTER MISHIMA K.K. |
| Manufacturer Street | 454-32 HIGASHINO NAGAIZUMI-CHO SUNTO-GUN |
| Manufacturer City | SCHIZOUKA, MISHIMA, JP-NOTA 41, JA |
| Manufacturer Country | JA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BECKMAN COULTER DXC 700 AU |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | DBF |
| Date Received | 2018-03-06 |
| Model Number | DXC 700 AU-10E |
| Catalog Number | B86444 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 928218000 US 928218000 |
| Brand Name | BECKMAN COULTER DXC 700 AU |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JJE |
| Date Received | 2018-03-06 |
| Model Number | DXC 700 AU-10E |
| Catalog Number | B86444 |
| 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 928218000 US 928218000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-06 |