MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-06-06 for LIPASE OSR6230 manufactured by Beckman Coulter Biomedical Limited.
[1974717]
A customer contacted beckman coulter inc. , (bci) in regards to an erroneously high lipase result of 156. 2u/l generated by the au681-03e chemistry analyzer. The reaction monitor for the instrument displayed a non-typical curve. A subsequent testing on an alternate instrument produced a lower result of 15. 39u/l, and the reaction monitor displayed a typical curve. The result was not reported out of the lab. There was no effect to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9133205]
Per customer, this issue re-occurs every few weeks, whereby the laboratory will obtain a sample result which displays atypical lipase values. The sampling order and contamination parameters have been checked by the customer contact and are correct. The specimen was returned to bci (b)(4) for investigation. Testing was conducted over three lots of lipase reagent, including the reagent lots used by the customer at the time of this event. The results from both, the au681-03e and the reference instrument across the three reagent lots are provided below. A root cause for this event has not been determined. Analyzer: au681-03e, rg lot 9830: 20. 84, rg lot 1026: 12. 17, rg lot 1173: 10. 03; alternate instrument, 12. 83,11. 04, 8. 79. Units: u/l.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-02082 |
| MDR Report Key | 2114834 |
| Report Source | 01,06 |
| Date Received | 2011-06-06 |
| Date of Report | 2011-05-09 |
| Date of Event | 2011-04-20 |
| Date Mfgr Received | 2011-05-09 |
| Date Added to Maude | 2012-02-21 |
| 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 | 0 |
| 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 BIOMEDICAL LIMITED |
| Manufacturer Street | LISMEEHAN O'CALLAGHAN'S MILLS |
| Manufacturer City | CO. CLARE,, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPASE |
| Generic Name | LIPASE REAGENT |
| Product Code | CDT |
| Date Received | 2011-06-06 |
| Model Number | NA |
| Catalog Number | OSR6230 |
| Lot Number | 9830 |
| ID Number | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER BIOMEDICAL LIMITED |
| Manufacturer Address | LISMEEHAN O'CALLAGHAN'S MILLS CO. CLARE, EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-06 |