MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-02-25 for AU640 CHEMISTRY ANALYZER AU643-02E, AU640 WITH ISE N1256100 manufactured by Beckman Coulter Mishima K.k..
[1930256]
A customer contacted beckman coulter inc. (bci) in regards erroneous low phenytoin result (<2. 5 mg/l) generated on au640 chemistry analyzer. The erroneous result was reported out of the laboratory and questioned by the physician. A fresh pour off sample was retested and resulted in higher result 13. 1 mg/l, which was within the therapeutic range. Patient treatment was not impacted by this event.
Patient Sequence No: 1, Text Type: D, B5
[9101805]
Au640 system using microgenics cedia tdm dilantin (phenytoin). Three level controls before and after the event was in range. Clot was detected at 7:15 am. Service was not dispatched. A root cause for this event it presumed a malfunction in sample aspiration or user error in sample handling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-00518 |
| MDR Report Key | 2001572 |
| Report Source | 06 |
| Date Received | 2011-02-25 |
| Date of Report | 2011-01-25 |
| Date of Event | 2011-01-21 |
| Date Mfgr Received | 2011-01-25 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2011-02-28 |
| 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 | 7149613436 |
| Manufacturer G1 | BECKMAN COULTER MISHIMA K.K. |
| Manufacturer Street | 454-32 HIGASHINO, NAGAIZUMI-CH SUNTO-GUN |
| Manufacturer City | SCHIZUOKA, JP-NOTA 411-0931 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 411-0931 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AU640 CHEMISTRY ANALYZER |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2011-02-25 |
| Model Number | AU643-02E, AU640 WITH ISE |
| Catalog Number | N1256100 |
| Lot Number | N/A |
| ID Number | N/A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER MISHIMA K.K. |
| Manufacturer Address | 454-32 HIGASHINO, NAGAIZUMI-CH SUNTO-GUN SCHIZUOKA, JP-NOTA 411-0931 JA 411-0931 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-25 |