MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-12-04 for OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER AU400-ISE N1254400 manufactured by Beckman Coulter Mishima K.k..
[21975056]
This mdr was initially submitted on (b)(6) 2011 within the 30 day deadline; however, inadvertently the year was entered as 2010 on the report number instead of 2011. Was 2050012-2010-08062. Should have been 2050012-2011-08062.
Patient Sequence No: 1, Text Type: N, H10
[22233143]
The customer contacted beckman coulter inc (bec) in regards to an erroneous sodium (na) result on a female, which was generated by the au400. The erroneous result was reported out laboratory; however, patient treatment was not impacted by the even. The sample was repeated higher result within the normal reference range was obtained and the result amended. The sample was heparinized plasma. Per customer: ise calibration data looks acceptable. Qc in range before and after event. Analyzer maintenance is current. On the day of the event, a field service engineer (fse) was dispatched. Per fse , the unit has been giving occasional low ise results. The fse noted the d-pot not draining properly following weekly maintenance performed on (b)(4) 2011, when the errors started. The fse replaced the d-pot to the drain, the ise started draining properly. Calibrated two times and ran qc two times, qc good. Verified repair per established procedures. Results meet published performance specifications. Root cause: clogged ise tubing and clogged waste tubing causing sample pot to not empty properly between samples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2011-08062 |
| MDR Report Key | 2356932 |
| Report Source | 06 |
| Date Received | 2011-12-04 |
| Date of Report | 2011-10-24 |
| Date of Event | 2011-10-24 |
| Date Mfgr Received | 2011-10-24 |
| Device Manufacturer Date | 2007-09-01 |
| Date Added to Maude | 2011-12-05 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ACID PHOSPHATASE, NAPHTHYL PHOSPHATE |
| Product Code | CKB |
| Date Received | 2011-12-04 |
| Model Number | AU400-ISE |
| Catalog Number | N1254400 |
| Lot Number | N/A |
| ID Number | N/A |
| 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-CH SUNTO-GUN SCHIZUOKA, JP-NOTA 411-0931 JA 411-0931 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-04 |