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 2016-03-30 for ACCESS 2 IMMUNOASSAY ANALYZER 81600N manufactured by Beckman Coulter.
[41544925]
The customer did not provide patient demographics such as age, sex, date of birth or weight. A beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument's performance discovered that the wash arm plate assembly was not tightened down or somehow had loosened up and this was causing bad aspiration from the aspirated probes. The fse tightened the screw and ran system check along with access total bhcg (5th is) precision runs on two levels of qc. Results of the system check and the precision runs were passing within specifications. In conclusion, the loose wash arm plate assembly was determined to be the cause of this event.
Patient Sequence No: 1, Text Type: N, H10
[41544926]
The customer reported obtaining false positive beta human chorionic gonadotropin (access total bhcg (5th is)) results on samples from four (4) patients that were generated on the laboratory's access 2 immunoassay system (serial number (b)(4)). The customer reanalyzed the patients' samples on the laboratory's alternate access 2 immunoassay system (serial number not supplied) and obtained results that did not correlate with the original results. The initial results were reported outside of the laboratory and were questioned by the nurse. Corrected reports were sent out. There was no change or impact to patient care or treatment in association with this event. The customer declined to provide patient data. The customer declined to provide system parameter data such as calibration, quality control (qc) and system checks. The customer stated that there were no issues with controls. To troubleshoot this issue, the customer stated that recalibration was performed using a new reagent pack and system check was performed. The system check failed with wash arm errors. Repeat of the system check generated additional errors. The customer did not supply sample handling/processing information and did not supply the sample centrifugation parameters such as speed, time, and temperature. 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 | 2122870-2016-00170 |
| MDR Report Key | 5536622 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-03-30 |
| Date of Report | 2016-03-08 |
| Date of Event | 2016-03-07 |
| Date Mfgr Received | 2016-03-08 |
| Device Manufacturer Date | 2010-09-30 |
| Date Added to Maude | 2016-03-30 |
| 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 | MR. JEFFREY KOLL |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9523681361 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS 2 IMMUNOASSAY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE, PRODUCT CODE: JJE |
| Product Code | NAL |
| Date Received | 2016-03-30 |
| Model Number | NA |
| Catalog Number | 81600N |
| Lot Number | NA |
| 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 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-30 |