MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-01 for OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER N3662700 manufactured by Beckman Coulter Mishima K.k..
[2223264]
The customer reported that erroneous, low methotrexate results were generated on the olympus au600 clinical chemistry analyzer for multiple patients. The quantity of involved patient results is unknown. Beckman coulter inc. Assessment of customer supplied data revealed multiple patient and quality control results however it is unknown as to whether these results were regarded as erroneous. The customer indicated that initial erroneous methotrexate results were reported outside of the laboratory. It is unknown as to whether there was an affect to the patient, including death, serious injury or modification to patient treatment as a result of the erroneous methotrexate results. The customer provided an example of the erroneous results. The initial erroneous methotrexate result was erroneously low and possessed an instrument "g" flag which represents a result which was lower than the dynamic range. Repeat testing yielded a methotrexate result which was higher. Patient demographic and sample collection/handling was not provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
[9426454]
Service was dispatched to the site prior to the event. The field service engineer upgraded the software and verified the instrument's performance via the execution of a successful quality control assessment. Beckman coulter inc. Evaluation of customer instrumentation operational parameters revealed that the customer was not running the instrument at the recommended manufacturer parameters. Beckman coulter inc. Assessment of the reaction monitor for one of the erroneous results showed that reagent r1 was being dispensed correctly. Beckman coulter inc. Evaluation of customer provided reaction monitor data indicates less sample in the reaction cuvette. The reason for this is unknown. A definitive root cause has not been determined to date with the information available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-06984 |
| MDR Report Key | 2318321 |
| Report Source | 05,06 |
| Date Received | 2011-11-01 |
| Date of Report | 2011-10-11 |
| Date of Event | 2011-10-05 |
| Date Mfgr Received | 2011-10-11 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2012-07-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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, P-NOTA 411-0931 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 411-0931 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY |
| Product Code | LAO |
| Date Received | 2011-11-01 |
| Model Number | NA |
| Catalog Number | N3662700 |
| Lot Number | NA |
| ID 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, P-NOTA 411-0931 JA 411-0931 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-01 |