MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-02 for ACCESS 2 IMMUNOASSAY ANALYZER 81600N manufactured by Beckman Coulter.
[32984368]
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 analyzer. The fse went on site and ran a dil test. The diltest was confirmed to be failing. The fse rebuilt the precision pump which entails replacing the two seals. Verifications performed were passing. The diltest was repeated and it passed within specifications. In conclusion, a hardware malfunction is the assignable cause of this event; malfunctioning seals of the precision pump failed to function properly to aspirate and/or deliver a volume required for dilution.
Patient Sequence No: 1, Text Type: N, H10
[32984369]
On (b)(6) 2015, the customer reported reproducibly erroneous diluted beta human chorionic gonadotropin (access diluted total bhcg (5th is)) results which were obtained on the laboratory's access 2 immunoassay system (serial number (b)(4)) for one (1) patient. The sample was originally run on the access 2 immunoassay system portion of the unicel dxc 600i synchron access clinical system (serial number (b)(4)) and a diluted total bhcg (5th is) result of 64,737. 6 iu/l was obtained. The sample was repeated on the same access 2 immunoassay system portion of the unicel dxc 600i synchron access clinical system and a diluted result of 65,289. 3 iu/l was generated. The customer was performing a correlation study so the same sample was repeated. The sample was repeated on the laboratory's alternative access 2 immunoassay system (serial number (b)(4)) and reproducibly high diluted total bhcg (5th is) results of 112,203. 1 iu/l and 116,792 iu/l were obtained. The same sample was sent to another lab for testing and a result recovery of 69,265 iu/l was obtained; correlating well with the results obtained on the access 2 immunoassay system portion of the unicel dxc 600i synchron access clinical system. The reproducibly high results obtained on the access 2 immunoassay system were questioned by the laboratory. The reproducibly erroneous diluted total bhcg (5th is) were generated as part of correlation study and were not reported outside of the laboratory. There was no report of patient injury or change in patient treatment associated with this event. Qc (quality controls), calibrations and system checks were all performing within assay and instrument specifications. The customer performed a dil test which failed. The patient sample was drawn in a plasma separator tube that was centrifuged for 5 minutes at an unknown speed. No issues with sample integrity were reported by the customer. A beckman coulter (bec) field service engineer (fse) was dispatched to assess the analyzer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2015-00790 |
| MDR Report Key | 5261161 |
| Date Received | 2015-12-02 |
| Date of Report | 2015-11-08 |
| Date of Event | 2015-11-08 |
| Date Mfgr Received | 2015-11-08 |
| Device Manufacturer Date | 2003-02-28 |
| Date Added to Maude | 2015-12-02 |
| 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 | 0 |
| Brand Name | ACCESS 2 IMMUNOASSAY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE, PRODUCT CODE: JJE |
| Product Code | NAL |
| Date Received | 2015-12-02 |
| 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 | 2015-12-02 |