MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-27 for UNICEL? DXI 600 ACCESS? IMMUNOASSAY SYSTEM A30260 manufactured by Beckman Coulter, Inc..
[2137767]
The customer contacted beckman coulter, inc. (bec) to report discrepant results for creatine kinase - mb (ck-mb) for one (1) patient sample assayed with access ck-mb reagent on a unicel dxi 600 access immunoassay system. The discrepant ck-mb results were reported out of the laboratory. On (b)(6) 2011, the customer reported an abnormally high ck-mb result for the patient. Later that day, the patient was intubated for complaints of respiratory failure. A cardiology consultation was called due to "abnormal labs and ecg, mild elevation of troponin i, marked elevation of ck-mb, normal total ck, and minimal elevation of bnp. " the patient had a central line placed around 23:00 on (b)(6) 2011. It is unclear if the elevated ck-mb result contributed to the decision to place the central line. The same patient specimen was re-assayed for ck-mb the following day ((b)(6) 2011). The customer reported two (2) ck-mb results which were discrepantly lower than the initial result and which recovered within the laboratory's reference range. A field service engineer (fse) was dispatched to the customer's site on (b)(6) 2011. The fse observed no unusual errors posted to the event log of the analyzer during the time of the event. The fse performed a system check of the analyzer which met all performance specifications. The fse reported that the customer had reran multiple patient samples in duplicate with no discrepant results observed. The fse reported that "the only problem observed is with a single patient. " a definitive root cause has not yet been determined for this event.
Patient Sequence No: 1, Text Type: D, B5
[9207824]
Result: discrepant data generated. Conclusion: a definitive root cause has not yet been determined. Quality control results were within the customer's established ranges at the time of the event. The customer is not questioning the results obtained from other patient samples. The customer is not questioning the performance of other assays on the analyzer. This medwatch report is related to another medwatch report filed for discrepant ck-mb results for the same patient but for a different specimen drawn and assayed on another day. Refer to medwatch report number 2122870-2011-02439.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-02438 |
| MDR Report Key | 2179913 |
| Report Source | 05,06 |
| Date Received | 2011-07-27 |
| Date of Report | 2011-06-22 |
| Date of Event | 2011-06-20 |
| Date Mfgr Received | 2011-06-22 |
| Device Manufacturer Date | 2009-11-19 |
| Date Added to Maude | 2011-07-27 |
| 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. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| 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 | UNICEL? DXI 600 ACCESS? IMMUNOASSAY SYSTEM |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | JHS |
| Date Received | 2011-07-27 |
| Model Number | DXI 600 |
| Catalog Number | A30260 |
| 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, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-07-27 |