MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-03 for AU681 CLINICAL CHEMISTRY ANALYZER AU681-02E, CHEMISTRY ANALYZER AU680 WITH ISE, 210V N3147200 manufactured by Beckman Coulter.
[19968438]
The customer experienced erratic potassium results on the ise side of their au681 instrument. The customer got a result of 6. 6, which, when repeat, resulted in a value of 4. 4. The day before, a result of 7. 6 was obtained and when repeated it was 4. 0. Erroneous results were generated but not reported outside the laboratory, so there was no effect to patient or change to patient treatment. During troubleshooting, the customer observed bubbles within the reference line.
Patient Sequence No: 1, Text Type: D, B5
[20481823]
A field service engineer (fse) was dispatched and upon arrival verified customer's issue. He replaced the reference( ref) valve. He also replaced the peristaltic pump tubings and all related ise tubings. He then calibrated the ise three times and ran qc. All results were within specifications. The instrument was operational. The manufacturer's reference # for this event is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[34092161]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612296-2013-00168 |
| MDR Report Key | 3496095 |
| Report Source | 05,06 |
| Date Received | 2013-12-03 |
| Date of Report | 2013-11-11 |
| Date of Event | 2013-11-10 |
| Date Mfgr Received | 2013-11-11 |
| Device Manufacturer Date | 2008-01-11 |
| Date Added to Maude | 2014-03-13 |
| 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 | AU681 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | MZV |
| Date Received | 2013-12-03 |
| Model Number | AU681-02E, CHEMISTRY ANALYZER AU680 WITH ISE, 210V |
| Catalog Number | N3147200 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2013-12-03 |