MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-06-08 for C8000 ALBUMIN BCP 7D54-20 manufactured by Abbott Manufacturing, Inc.
[17491414]
A laboratory technician was attempting to open a carton of the clinical chemistry albumin bcp reagent for use on the architect c8000 analyzer. The technician was using a box cutter knife to open the carton. The cutter became stuck during this procedure and when the technician moved the knife downward, she cut her thumb. The technician went to the emergency department and received five stitches. No further treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
[17684052]
The customer noted that no further assistance was required, but then offered a further explanation relating to the event. The customer has arthritis and finds the boxes difficult to open without the use of a cutting instrument. The customer stated that no blood splashed onto her lab coat or face shield. No mention of whether the customer was using gloves at the time of the event. The customer is fine and returned to work after receiving the stitches. The investigation demonstrated that the abbott clinical chemistry albumin bcp assay was not the cause of the event and that the product continues to perform within its intended use, label claims and specifications. No deficiency related to the performance of the device was identified. This is a final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2007-00030 |
| MDR Report Key | 863569 |
| Report Source | 05,06 |
| Date Received | 2007-06-08 |
| Date of Report | 2007-05-16 |
| Date of Event | 2007-05-16 |
| Date Mfgr Received | 2007-05-16 |
| Date Added to Maude | 2007-09-04 |
| 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 | DR. DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C8000 ALBUMIN BCP |
| Generic Name | QUANTITATION OF ALBUMIN IN HUMAN SERUM OR PLASMA |
| Product Code | CJW |
| Date Received | 2007-06-08 |
| Model Number | NA |
| Catalog Number | 7D54-20 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 858684 |
| Manufacturer | ABBOTT MANUFACTURING, INC |
| Manufacturer Address | 820 MISSON ST SOUTH PASADENA CA 91030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-06-08 |