MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-03-19 for AU5400 CLINICAL CHEMISTRY ANALYZER (AU5431-02 UG ANALYZER) N1464600 manufactured by Beckman Coulter.
[18280032]
A customer contacted beckman coulter (bec) in regards to obtaining erroneously elevated lithium (li+) patient results generated on the (b)(4) ug clinical chemistry analyzer. The erroneous results were reported out of the laboratory. The customer confirmed that four (4) corrected reports were issued for this event. The customer did not provide patient data for this event. There is no report of patient injury requiring medical intervention or change to patient treatment attributed to or connected with this event.
Patient Sequence No: 1, Text Type: D, B5
[18325886]
Bec customer technical support (cts) informed the customer that the problem is related to the reagent bottles and the movement of the bottles in the compartment. The customer observed that the bottles appeared to be malformed. Cts recommended the customer to pour the reagent into a white bottle and run as a fixed reagent. The customer stated that changed the bottle eliminated the problem. The customer no longer has the defected bottles because they were scrapped. A bec field service engineer (fse) was dispatched for this event. The fse noted that the customer replaced the sample probe and r1 probe and checked the syringes prior to arrival. The fse rechecked the probes, syringes, and alignments. The customer calibrated and ran quality control (qc); all yielded within limits. The fse performed several adjustments and replaced multiple parts; however erratic recovery of patient samples still remains.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612296-2013-00042 |
| MDR Report Key | 3011392 |
| Report Source | 05,06 |
| Date Received | 2013-03-19 |
| Date of Report | 2013-02-19 |
| Date of Event | 2013-02-19 |
| Date Mfgr Received | 2013-02-19 |
| Device Manufacturer Date | 2005-08-20 |
| Date Added to Maude | 2013-05-21 |
| 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 BOULEVARD |
| 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, 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 | AU5400 CLINICAL CHEMISTRY ANALYZER (AU5431-02 UG ANALYZER) |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | NDW |
| Date Received | 2013-03-19 |
| Model Number | AU5431-02 UG |
| Catalog Number | N1464600 |
| Lot 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 |
| Manufacturer Address | 250 S. KRAEMER BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-19 |