MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-23 for SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT PHOSPHORUS REAGENT A09426 manufactured by Beckman Coulter, Inc..
[2358920]
Customer called on (b)(6) 2011 to report that the unicel dxc 600 synchron system generated falsely low patient results. Customer stated that there were precision and accuracy issues with the phosphorus (phs) assay, lot #m010604. The field service engineer (fse) ordered a collar wash to address the issue. On (b)(4) 2011, the fse replaced the cartridge chemistry sample probe and collar wash, and then ran precision and correlation tests between the two dxc instruments in the laboratory. Both units were correlating and were within specifications. However, customer continued to have phs issues as the quality control recovery was low. The customer technical specialist (cts) sent a replacement syringe and a t-valve to address the issue. On (b)(4) 2011, the fse replaced the reagent with a new phs reagent lot, which appears to have resolved the issue. Customer stated that patient treatment was not affected as the results were amended prior to treatment. Customer no longer has access to the patient data from (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
[9485188]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-07961 |
| MDR Report Key | 2346704 |
| Report Source | 05,06 |
| Date Received | 2011-11-23 |
| Date of Report | 2011-07-11 |
| Date of Event | 2011-07-11 |
| Date Mfgr Received | 2011-07-11 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2012-07-18 |
| 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 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821623 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 6232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT |
| Generic Name | PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS |
| Product Code | CEO |
| Date Received | 2011-11-23 |
| Model Number | PHOSPHORUS REAGENT |
| Catalog Number | A09426 |
| Lot Number | M010604 |
| Device Expiration Date | 2012-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-23 |