MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-10-11 for ACCESS 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter.
[56922364]
A beckman coulter (bec) field service engineer (fse) was dispatched to the customer's site to assess the instrument's performance. Inspection of the substrate system revealed a pinched substrate probe; fse replaced the substrate probe. After probe replacement, the instrument primed without error. Access folate calibration and qc results met specifications. Verification testing passed within published performance specifications. In conclusion, the cause of this event is a hardware malfunction of the substrate probe.
Patient Sequence No: 1, Text Type: N, H10
[56922365]
The customer reported obtaining several low folate (access folate) patient sample results on the laboratory's access 2 immunoassay system (serial number (b)(4)). The customer attempted to recalibrate the access folate assay, but the calibrations failed due to elevated coefficients of variation (%cvs) and bad fit. The initial access folate patient sample results were not released from the laboratory. There was no impact or change to patient treatment in conjunction with this event. Access folate calibrations were failing to meet specifications. Access folate quality control (qc) started failing prior to the event. The customer reported that system check performed on (b)(6) 2016 had failed the substrate ratio specification; the customer had not repeated system check since the failure. The customer did not provide information regarding patient sample collection and processing. There was no report of sample integrity issues from the customer. The customer did not provide patient sample results or the exact date of patient sample analysis. Service was requested and a beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument's performance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2016-00482 |
| MDR Report Key | 6016336 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-10-11 |
| Date of Report | 2016-09-19 |
| Date of Event | 2016-09-09 |
| Date Mfgr Received | 2016-09-19 |
| Device Manufacturer Date | 2014-06-18 |
| Date Added to Maude | 2016-10-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ANGELA KILIAN |
| Manufacturer Street | 1000 HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 553181084 |
| Manufacturer Country | US |
| Manufacturer Postal | 553181084 |
| Manufacturer Phone | 9523681330 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA 553181084 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 553181084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS 2 IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE, |
| Product Code | CGN |
| Date Received | 2016-10-11 |
| Catalog Number | 81600N |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA 553181084 US 553181084 |
| Brand Name | ACCESS 2 IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE, |
| Product Code | JJE |
| Date Received | 2016-10-11 |
| Catalog Number | 81600N |
| 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 | 1000 LAKE HAZELTINE DRIVE CHASKA 553181084 US 553181084 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-11 |