MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-10-10 for OLYMPUS AU481-10E CLINICAL CHEMISTRY ANALYZER (WITH ISE) AU481-10E (WITH ISE) B12183 manufactured by Beckman Coulter.
[3911692]
After receiving the urgent product correction letter reference in the field action (b)(4), the customer contacted beckman coulter (bec) to report that the olympus au481-10e (au480) with ion selective electrode (ise) clinical chemistry analyzer generated erroneously high potassium (k) patient results which upon repeat were normal. The customer indicated that the erroneous results were reported out of the laboratory. The customer provided an example of this event, where the initial result yielded a value of 12. 3 meq/l and upon repeat yielded a value of 4. 5 meq/l (reference range: 3. 5 - 5. 3 meq/l). The repeat result was considered the correct result. Patient demographics (age, date of birth, gender, and weight) were not provided by the customer. There was no death nor injury or change to patient treatment attributed to or connected to this event.
Patient Sequence No: 1, Text Type: D, B5
[11151013]
Sample collection and centrifugation information was not available. Quality control (qc) was run prior to and after the event and recovered within the laboratory established ranges. The customer confirmed the presence of bubbles in the tubing connected to the reference valve. A bec field service engineer (fse) was dispatched on (b)(4) 2013 to evaluate the instrument. The fse also confirmed the presence of bubbles in the reference line. The fse replaced the reference valve and primed the line until all air was removed. The fse confirmed the instrument was returned to working order. The erroneous k results were most likely caused by an ise reference valve malfunction as indicated in the urgent product correction letter reference in the field action (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612296-2013-00144 |
| MDR Report Key | 3405465 |
| Report Source | 05,06 |
| Date Received | 2013-10-10 |
| Date of Report | 2013-09-16 |
| Date of Event | 2013-09-16 |
| Date Mfgr Received | 2013-09-16 |
| Device Manufacturer Date | 2012-04-12 |
| Date Added to Maude | 2014-01-14 |
| 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, SCHIZUOKA, JP-NOTA 411-0931 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 411-0931 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 2050012-08/22/2013-008 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS AU481-10E CLINICAL CHEMISTRY ANALYZER (WITH ISE) |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | MZV |
| Date Received | 2013-10-10 |
| Model Number | AU481-10E (WITH ISE) |
| 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 BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-10 |