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 AU400 CLINICAL CHEMISTRY ANALYZER AU403-02E N1254400 manufactured by Beckman Coulter Mishima K.k..
[2315255]
The customer contacted beckman coulter inc (bec) in regards to multiple erroneous results generated by the au400 when compared to an alternate au analyzer. The erroneous results were not reported out of the laboratory; hence patient treatment was not impacted by this event. Patient results were requested, however they were not provided. Per customer, the analyzer got multiple clot detect errors and multiple tests were unable to calibrate. On the day of the event, a field service engineer (fse) found internal probe wash is failing and order a replacement. The fse verified repair per established procedures. Results meet published performance specifications. System validation documented in customer qc record. On (b)(4) 2011, the fse verified insufficient internal sample and reagent probe wash. Using the unused au400 in the mpls cardio lab found the degasser to be limiting the flow to the internal probe wash. Problem resolved. Verified repair per established procedures. Results meet published specifications. System validation documented in customer qc record. The root cause for this event is the internal probe wash is failing because degasser is limiting the flow to the internal probe wash.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2011-08234 |
| MDR Report Key | 2357183 |
| Report Source | 06 |
| Date Received | 2011-12-04 |
| Date of Report | 2011-11-04 |
| Date of Event | 2011-11-03 |
| Date Mfgr Received | 2011-11-04 |
| Device Manufacturer Date | 2002-11-02 |
| 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 | AU400 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ACID PHOSPHATASE, NAPHTHYL PHOSPHATE |
| Product Code | CKB |
| Date Received | 2011-12-04 |
| Model Number | AU403-02E |
| 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 |