MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-11-06 for AU480 CLINICAL CHEMISTRY ANALYZER WITH ISE AU481-02E, CHEMISTRY ANALYZER AU480 WITH ISE AND P N3660200 manufactured by Beckman Coulter.
[17613516]
A customer reported they were generating erratic potassium results. The customer provided the following evidence: a result of 6. 4 mmol/l repeated at 4. 8 mmol/l. A result of 7. 2 mmol/l repeated at 4. 7 mmol/l. A result of 7. 8 mmol/l repeated at 4. 8 mmol/l. The customer stated that these results were not reported outside of the lab and there was no change to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[17758375]
At the request of the hotline the customer performed a mid-standard and reference solution prime. When performing this action the customer observed bubbles in the reference line. A field service engineer (fse) was dispatched and confirmed the system contained a defective reference valve. The fse confirmed the presence of bubbles in the reference line. The fse replaced the reference valve mu7638. No further ise issues were observed after replacement of the reference valve. The ise errors generated were caused by a reference valve malfunction. A defective reference valve causes the relationship of pressures within the ise lines to become abnormal. This permits the intrusion of the reference liquid, which does not normally enter into electrode section of the flowcell. The reference liquid can mix with the sample liquid, resulting in erroneous results. The available evidence shows that the erroneously high potassium arose from a defective reference valve. No further issues were seen after the replacement of this part. A capa investigation has been initiated to address this issue. The manufacturer's reference # for this event is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612296-2013-00154 |
| MDR Report Key | 3453971 |
| Report Source | 05,06 |
| Date Received | 2013-11-06 |
| Date of Report | 2013-10-23 |
| Date of Event | 2013-10-23 |
| Date Mfgr Received | 2013-10-23 |
| Device Manufacturer Date | 2010-12-15 |
| Date Added to Maude | 2014-02-05 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2050012-08/22/2013-008 |
| 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 | 2013-11-06 |
| Model Number | AU481-02E, CHEMISTRY ANALYZER AU480 WITH ISE AND P |
| Catalog Number | N3660200 |
| 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 | 1. Life Threatening | 2013-11-06 |