MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-05-12 for LIPASE OSR6230 manufactured by Beckman Coulter Biomedical Limited.
[1979363]
A customer contacted beckman coulter inc. (bci) in regards to an erroneously high lipase result of 461. 0 u/l generated by (b)(4) chemistry analyzer. The reaction monitor for the instrument displayed a non-typical curve. The result was not reported out of the laboratory. Subsequent testing on an alternate instrument produced a lower result of 67. 45 u/l and the reaction monitor displayed a typical curve. There was no effect to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9107603]
There was no issue with control recovery and no other samples were affected at this time. The customer indicated that this issue re-occurs every few weeks. The customer did not retain the sample for further investigation. The customer has been requested to retain any further samples which demonstrate atypical lipase values for investigation. A copy of hard drive data was requested for investigation. The sampling order and contamination parameters have been changed by the laboratory. Since these changes were implemented no more atypical lipase values have been obtained.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 2050012-2011-01729 |
MDR Report Key | 2087736 |
Report Source | 01,06 |
Date Received | 2011-05-12 |
Date of Report | 2011-03-28 |
Date of Event | 2011-03-09 |
Date Mfgr Received | 2011-03-28 |
Device Manufacturer Date | 2010-06-01 |
Date Added to Maude | 2012-02-13 |
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 BOULEVARD |
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 |
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 | 2011-05-12 |
Model Number | NA |
Catalog Number | OSR6230 |
Lot Number | 1026 |
ID Number | NA |
Device Expiration Date | 2012-06-01 |
Operator | HEALTH PROFESSIONAL |
Device Eval'ed by Mfgr | * |
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 | 2011-05-12 |