MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-01-03 for AU400 CLINICAL CHEMISTRY ANALYZER AU403-02E N1254400 manufactured by Beckman Coulter Mishima K.k..
[17102888]
The customer reported two erroneous high ethanol results generated on the au400 clinical chemistry analyzer. The results were reported out of the laboratory and questioned by the doctor. Patient treatment was not impacted by this event. Qc out high after event. Prior to the event, the instrument had a new sample probe, new lamp, wash pump replaced, and cuvettes cleaned. Post the event, the customer use a new lot of calibrator and fresh reagent, cleaned water tank, replaced "beaded" water tanks on water system, and cultured cleaned. On (b)(4) 2011, a field service engineer (fse) was unable to replicate as problem is intermittent. Verified all alignments, temperatures and wash usage. All consumables have been replaced. The customer is going to run all alcohols on the au640 in duplicate. On (b)(4) 2011, fse decontaminated the au400 and all qc were within specification. Will monitor. Root cause for the event appears to be the water system and contagion of the au400
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2012-00016 |
| MDR Report Key | 2395954 |
| Report Source | 06 |
| Date Received | 2012-01-03 |
| Date of Report | 2011-11-30 |
| Date of Event | 2011-11-24 |
| Date Mfgr Received | 2011-11-30 |
| Device Manufacturer Date | 2002-11-01 |
| Date Added to Maude | 2012-06-19 |
| 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 | MRS. 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-CH |
| Manufacturer City | SUNTO-GUN, SCHIZUOKA, JP-NOTA 411-0931 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 411-0931 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AU400 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ACID PHOSPHATASE, NAPHTHYL PHOSPHATE |
| Product Code | CKB |
| Date Received | 2012-01-03 |
| Model Number | AU403-02E |
| Catalog Number | N1254400 |
| Lot Number | N/A |
| ID Number | N/A |
| 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 | 2012-01-03 |