MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-07-18 for ACCESS 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter, Inc..
[2815498]
The customer reported that erroneously elevated creatine kinase-mb isoenzyme (ck-mb) patient results, above the normal reference range of the assay, were generated on an access 2 immunoassay system for one patient. Beckman coulter inc. Assessment of customer supplied patient data indicated that upon repeat testing of an aliquot of the original sample, the repeat result was lower, within the normal reference range of the assay and regarded as valid. The erroneous ck-mb results were not reported out of the laboratory and hence there was no death, serious injury or modification to patient treatment associated with this event. The sample was a fresh venous plasma draw in a lithium heparin tube. The sample was centrifuged at three thousand five hundred revolutions per minute for six minutes prior to testing. The customer indicated that temperature in the laboratory was elevated on the date of the event. The reagent and calibrator lots associated with this event were 123056 and 119344 respectively. Beckman coulter inc. Assessment of customer supplied instrument assay performance data indicated that quality control samples run before and after the incident were within the customer's established limits. System check data from (b)(6) 2012 showed all parameters passing within specifications. No error messages were associated with this event. No other patient results were questioned as part of this event.
Patient Sequence No: 1, Text Type: D, B5
[9983256]
Service was dispatched to the site. The field service engineer (fse) verified alignments, pressures, mixer speed and ultrasonics were within specifications. The fse performed a system check, quality control assessment and high sensitivity system check which all generated acceptable results. No hardware problems were found. System verified as performing to published performance specifications. A cause for this event could not be determined with the information supplied.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-01604 |
| MDR Report Key | 2659327 |
| Report Source | 05,06 |
| Date Received | 2012-07-18 |
| Date of Report | 2012-07-03 |
| Date of Event | 2012-07-03 |
| Date Mfgr Received | 2012-07-03 |
| Device Manufacturer Date | 2005-10-18 |
| Date Added to Maude | 2012-10-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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, INC |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS 2 IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2012-07-18 |
| Model Number | NA |
| Catalog Number | 81600N |
| Lot Number | NA |
| ID 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, INC. |
| Manufacturer Address | 250 S KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-18 |