MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-02-24 for ACCESS 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter.
[68415198]
(b)(6). A field service engineer (fse) was dispatched to the customer site. The fse replaced hardware parts to include replacement of the wash carousel bearings that were identified to have been damaged/deteriorated by spilled wash buffer. The damaged wash carousel bearings were causing rough movements of the reaction vessels (rvs) and rough movements of the wash carousel resulting in splashing of the reactants. There is sufficient evidence to determine a hardware malfunction as the cause of this event. Beckman coulter (bec) internal patient identifier for this report is (b)(6). All mdrs associated with this report are: 2122870-2017-00010, 2122870-2017-00011, 2122870-2017-00012, 2122870-2017-00015, 2122870-2017-00016, 2122870-2017-00017, 2122870-2017-00018, 2122870-2017-00019.
Patient Sequence No: 1, Text Type: N, H10
[68415199]
The customer reported elevated dimeric inhibin a (access inhibin a) results had been generated for multiple patients on the customer's access2 immunoassay system (serial number (b)(4)). The customer received the latest report from their external quality assurance (eqa) program for antenatal screening and determined that they had reported an eqa access inhibin a survey result that was 5 times the instrument median. Upon receipt of this report, the customer repeated patient samples that were tested for access inhibin a who were reported as an increase risk. Repeat analysis of some the patient samples recovered with lower results, no longer in the increased risk category. Calibration data was not provided. System checks performed on (b)(6) 2017 failed to meet specifications with elevated % cv results. There were some instances of erratic access inhibin a quality control (qc) results generated around the time of this event. Patient sample collection and processing information was not provided. This report addresses the non-reproducible elevated access inhibin a results for one patient (identified as patient 6) obtained on (b)(6) 2017. Additional reports are as follows: 2122870-2017-00011 addresses the non-reproducible elevated access inhibin a results obtained on (b)(6) 2016 for one patient. Report 2122870-2017-00012 addresses the non-reproducible elevated access inhibin a results obtained on (b)(6) 2017 for three patients. Report 2122870-2017-00016 addresses the non-reproducible elevated access inhibin a results obtained on (b)(6) 2017 for one patient. Report 2122870-2017-00017 addresses the non-reproducible elevated access inhibin a results obtained on (b)(6) 2016 for one patient. Report 2122870-2017-00018 addresses the non-reproducible elevated access inhibin a results obtained on (b)(6) 2016 for one patient. Report 2122870-2017-00019 addresses the non-reproducible elevated access inhibin a results obtained on (b)(6) 2016 for one patient. Report 2122870-2017-00010 addresses the non-reproducible elevated access inhibin a results obtained on (b)(6) 2017 for one patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2017-00015 |
| MDR Report Key | 6357028 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-24 |
| Date of Report | 2017-02-21 |
| Date of Event | 2017-01-23 |
| Date Mfgr Received | 2017-02-21 |
| Device Manufacturer Date | 2008-08-15 |
| Date Added to Maude | 2017-02-24 |
| 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 | ANGELA KILIAN |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9523681330 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 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 SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE, PRODUCT CODE: JJE |
| Product Code | NDR |
| Date Received | 2017-02-24 |
| 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 MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-24 |