MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-03-22 for ACCESS? 2 IMMUNOASSAY ANALYZER ACCESS 2 81600N manufactured by Beckman Coulter.
[22040516]
A customer reported to beckman coulter that the access 2 immunoassay analyzer generated an erroneously low ck-mb result, below the normal reference range, for one patient. The customer performed a repeat testing on the same instrument and obtained a result within the normal reference range. The customer stated that the erroneous result was not reported out of the laboratory. There was no report of death, injury, or change to patient treatment in connection with this event. The customer used the below reagent and calibrator for ck-mb assay: access ck-mb reagent pack, catalogue number 386371, lot number 225901; access ck-mb calibrators, catalogue number 386372, lot number 220861.
Patient Sequence No: 1, Text Type: D, B5
[22364298]
Beckman coulter field service engineer (fse) visited the customer's site on (b)(4) 2013 and inspected the system. The fse found bubbles in the wash pump, and replaced the wash pump lower seal and o-ring. The fse cleaned the wash and precision valves, the wash carousel, and the incubator tracks, and verified alignments were within specifications. The fse replaced all three aspirate probes and the substrate probe. The fse found the high power ultrasonics voltage was 220 vac (specification is 197 +/- 3 vac), and adjusted the ultrasonics voltage to within the specification. The fse performed a system check, which passed with all parameters within specifications. The fse completed a 20-replicate precision run to verify accutni precision was within the specifications, and verified accutni quality control was within the laboratory's established limits. The fse verified that the instrument was performing to the published performance specifications. The related events that occurred on (b)(6) 2013 at the customer's laboratory are documented in mdr# 2122870-2013-00291 and 2122870-2013-00270, respectively.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2013-00266 |
| MDR Report Key | 3017777 |
| Report Source | 05,06 |
| Date Received | 2013-03-22 |
| Date of Report | 2013-02-25 |
| Date of Event | 2013-02-24 |
| Date Mfgr Received | 2013-02-25 |
| Device Manufacturer Date | 2012-01-24 |
| Date Added to Maude | 2013-05-14 |
| 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 |
| 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 | 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 ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2013-03-22 |
| Model Number | ACCESS 2 |
| Catalog Number | 81600N |
| 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 | 2013-03-22 |