MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-02-12 for UNICEL? DXC 600 SYNCHRON? SYSTEM A11810 manufactured by Beckman Coulter.
[4134857]
A customer noted three (3) erroneously high patient results on %a1c for the hba1c- assay when running on their dxc 600 pro instrument. The customer's reference range for female patients is 4. 5-5. 9%. The reported results for these patients were 6. 4-6. 5%. The physician questioned the results and indicated all 3 patients were administered the diabetic medication metformin after results were obtained on (b)(6) 2014. A week later the medication was stopped after the physician questioned the results. The patients were all redrawn and samples were sent to a local reference lab obtaining lower results. Amended results were obtained in the 5. 0-5. 6% range. No known patient health consequences were noted by the customer, when inquiring to the physician, after medication was administered and then stopped.
Patient Sequence No: 1, Text Type: D, B5
[11653916]
A field service engineer (fse) was dispatched four separate times between (b)(4) 2014. Numerous hardware components for both sample and reagent handling were replaced and this resolved the issues. The specific cause of the event is unknown. There is no further information available on the patients involved. Customer indicated they have filed risk management documentation with the state of washington. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2014-00086 |
| MDR Report Key | 3625783 |
| Report Source | 05,06 |
| Date Received | 2014-02-12 |
| Date of Report | 2014-01-22 |
| Date of Event | 2014-01-16 |
| Date Mfgr Received | 2014-01-22 |
| Device Manufacturer Date | 2007-03-12 |
| Date Added to Maude | 2014-02-13 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 600 SYNCHRON? SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | PDJ |
| Date Received | 2014-02-12 |
| Model Number | NA |
| Catalog Number | A11810 |
| 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. Other | 2014-02-12 |