MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-06-04 for AU5400 CLINICAL CHEMISTRY ANALYZER AU5400-30 N1464600 manufactured by Beckman Coulter.
[4686060]
The customer reported obtaining a potassium result with an exclamation point flag, "! ", for one patient on an au5400 clinical chemistry analyzer. The flag indicates the analyzer was unable to calculate concentration. The patient sample was rerun and a result was obtained without flags. There were no patient results released from the laboratory and there was no change to patient treatment in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
[11958072]
A beckman coulter (bec) field service engineer (fse) was dispatched to the customer's site. The fse found a rusty grounding point at the bottom of the ion selective electrode (ise) unit. The fse stated that because ise unit was not grounded, it would pick up extraneous noise. The fse cleaned the grounding point and performed a precision study. There were no further reports of issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612296-2014-00084 |
| MDR Report Key | 3846742 |
| Report Source | 05,06 |
| Date Received | 2014-06-04 |
| Date of Report | 2014-05-13 |
| Date of Event | 2014-05-12 |
| Date Mfgr Received | 2014-05-13 |
| Device Manufacturer Date | 2003-07-10 |
| Date Added to Maude | 2014-07-03 |
| 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 |
| Manufacturer City | SUNTO-GUN, 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 | AU5400 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | MZV |
| Date Received | 2014-06-04 |
| Model Number | AU5400-30 |
| Catalog Number | N1464600 |
| Lot Number | NA |
| ID Number | SW VERSION 5.5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-04 |