MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-28 for AU480 CLINICAL CHEMISTRY ANALYZER WITH ISE AU481-10E B12183 manufactured by Beckman Coulter.
[4095097]
A customer reported the generation of an erroneous potassium (k) result on their au480 analyzer. An electrical burning smell from the instrument was also reported. The customer obtained a result of 7. 9 mmol/l. They repeated the patient sample on the au480 and received 3 inconsistent results of 3. 7, 5. 9, 10. 2 mmol/l respectively. The result was not reported outside the laboratory so there was no change to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[11541097]
A field service engineer (fse) was dispatched. Upon inspection of the ise unit and flow cell, the fse observed air in the flow cell. The fse also noticed a pin hole in the tube between the dilution pot and the flow cell. He replaced the tubing and the air stopped. He recalibrated successfully and no more issues were identified. The fse also carried out instrument activities to identify the burning smell, however, he could not replicate the burning smell reported by the customer. The manufacturer reference number for this event is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612296-2014-00015 |
| MDR Report Key | 3596196 |
| Report Source | 05,06 |
| Date Received | 2014-01-28 |
| Date of Report | 2014-01-07 |
| Date of Event | 2014-01-07 |
| Date Mfgr Received | 2014-01-07 |
| Device Manufacturer Date | 2012-07-13 |
| Date Added to Maude | 2014-04-23 |
| 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 | 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 411-093 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 411-093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AU480 CLINICAL CHEMISTRY ANALYZER WITH ISE |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | MZV |
| Date Received | 2014-01-28 |
| Model Number | AU481-10E |
| Catalog Number | B12183 |
| Lot 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 |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-28 |