MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2009-09-04 for BECKMAN COULTER OLA2500 LAB AUTOMATION NA manufactured by Olympus Life Science Research Europa.
[16035558]
Complaint was received from outside the usa. The customer reported an aliquot tube with two different barcode labels.
Patient Sequence No: 1, Text Type: D, B5
[16115218]
No information has been received to suggest any ill effects associated with this event. Double labeling occurred on an aliquot tube because the operator did not follow instructions to check the label roll in the printer and remove the first label when an on-screen error message appeared. Both labels were affixed to the same aliquot tube. The printer was investigated by the manufacturer and no obvious error could be detected. If the investigation reveals significant new information, a follow-up will be submitted. Labeling in the (b)(4) user guide states action to be followed in the event a printer error message occurs and is considered adequate. Beckman coulter, inc. Is not aware of any incidence of this type reported in the (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006655511-2009-00001 |
| MDR Report Key | 1466352 |
| Report Source | 01,06,07 |
| Date Received | 2009-09-04 |
| Date of Report | 2009-09-04 |
| Date of Event | 2009-08-07 |
| Date Mfgr Received | 2009-08-07 |
| Device Manufacturer Date | 2005-02-01 |
| Date Added to Maude | 2011-03-30 |
| 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 | DAVID DAVIS |
| Manufacturer Street | 4300 N. HARBOR BLVD. |
| Manufacturer City | FULLERTON CA 92835 |
| Manufacturer Country | US |
| Manufacturer Postal | 92835 |
| Manufacturer Phone | 9726194710 |
| Manufacturer G1 | OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH |
| Manufacturer Street | RUPPERT-MAYER-STRASSE 44 |
| Manufacturer City | MUENCHEN 81379 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 81379 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BECKMAN COULTER OLA2500 LAB AUTOMATION |
| Generic Name | LAB AUTOMATION |
| Product Code | JJG |
| Date Received | 2009-09-04 |
| Model Number | OLA2500 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS LIFE SCIENCE RESEARCH EUROPA |
| Manufacturer Address | MUNICH GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-04 |