MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-11 for AU480 CLINICAL CHEMISTRY ANALYZER WITH ISE AU481-10E B12183 manufactured by Beckman Coulter.
[4105792]
A customer reported the generation of erroneous results for potassium (k) and sodium (na). No erroneous results were reported out of the lab so there was no affect to patient treatment. The original results in mmol/l were: na = 106, k = 2. 8, and cl = 82. The sample was auto repeated and obtained results na = 129 and k 3. 4 mmol/l with no repeat on the cl. The customer stated they ran a third repeat on their back up analyzer and reported the following: na = 139, k = 3. 7, and cl = 107 in mmol/l. The customer also stated all calibration and qc had been performed and were all acceptable. Review of the ise calibration slopes showed a detectable shift down in the slope recovery, but still within acceptable ranges. Review of the qc data provided shows that the original qc for ise analytes was running on the low side. Na was running at the low end of the acceptable range.
Patient Sequence No: 1, Text Type: D, B5
[11508126]
A field service engineer was dispatched to the site. The fse inspected the ise and provided the following service: replaced y tubing, adjusted j-nozzle alignment, cleaned d-pot and drain tubing. He also replaced the ise reference valve. Fse stated there was no fluid movement in the reference lines coming from the valve. He noted a bubble in the line that would not prime out. After the ref valve was replaced, the bubble primed out. The ise system was totally primed and calibrated 4 times with stable and acceptable recoveries for slopes. Customer performed qc and all met the established ranges close to mean. The manufacturer's reference # for this event is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612296-2013-00180 |
| MDR Report Key | 3516277 |
| Report Source | 05,06 |
| Date Received | 2013-12-11 |
| Date of Report | 2013-11-26 |
| Date of Event | 2013-11-26 |
| Date Mfgr Received | 2013-11-26 |
| Device Manufacturer Date | 2013-04-09 |
| Date Added to Maude | 2014-03-25 |
| 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 | 2013-12-11 |
| 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 | 2013-12-11 |