MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-11-15 for OLYMPUS AU5421 CLINICAL CHEMISTRY ANALYZER WITH 2 FLOWCELL ISE N1683100 manufactured by Beckman Coulter Mishima K.k..
[2362607]
A customer reported to beckman coulter, inc. (bec) that olympus au5421 clinical chemistry analyzer generated an erroneously elevated total protein result of 114 g/l. The result was not reported out of the laboratory as it was not consistent with the laboratory's expectation for the patient. Repeat testing produced 67 g/l, which was in line with the expected result. There was no effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
[9464078]
The sample was a serum collected in 7ml bd tube, and was centrifuged for 7 minutes at 3250 rpm, 20c. Qc produced expected results before and after the event. The laboratory assessed the reaction profile for this result and noted an unexpected electrical spike in early stages of the reaction curve. There was no error message or flagging associated with this event. Bec field service engineer (fse) visited the site next day and identified a blocked drainage from the cuvettes. The issue was corrected and the instrument has been performing acceptably.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-07619 |
| MDR Report Key | 2337492 |
| Report Source | 01,05,06 |
| Date Received | 2011-11-15 |
| Date of Report | 2011-10-18 |
| Date of Event | 2011-10-17 |
| Date Mfgr Received | 2011-10-18 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2012-07-16 |
| 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 BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER MISHIMA K.K. |
| Manufacturer Street | 454-32 HIGASHINO,NAGAIZUMI-CHO SUNTO-GUN |
| Manufacturer City | SCHIZUOKA, JP-NOTA 411-0931 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 411-0931 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS AU5421 CLINICAL CHEMISTRY ANALYZER WITH 2 FLOWCELL ISE |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | CEK |
| Date Received | 2011-11-15 |
| Model Number | AU5421 |
| Catalog Number | N1683100 |
| 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 MISHIMA K.K. |
| Manufacturer Address | 454-32 HIGASHINO,NAGAIZUMI-CHO SUNTO-GUN SCHIZUOKA, JP-NOTA 411-0931 JA 411-0931 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-15 |