MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-06 for SAMPLE CUPS, 0.5 ML 651412 manufactured by Beckman Coulter, Inc..
[2282701]
Customer reported to beckman coulter, inc. (bec) that on (b)(6) 2011, she was running six specimens in 0. 5 ml sample cups on one of the racks of the access 2 immunoassay system. The instrument displayed qns (quantity not sufficient) errors on the tests that were being run on those specimens. Customer reported that all the cups were filled equally but at the end of the run, cup 1 and 6 was empty and seemed to have leaked. The customer reported she refilled new cups with specimen. The new cups ran without error. The customer reported that they have determined that more 0. 5 ml sample cups with lot 1042839 have leaks. Customer reported that not every 0. 5 ml sample cup lot 1042839 was leaking. The customer reported that they have stopped using 0. 5 ml sample cups lot 1042839 and have not noticed any further leaks. Customer reported that they were unable to observe any cracks or holes in the leaking sample cups but over time the fluid level decreased in the sample cups. Customer reported that the cups were stored appropriately and did not believe any damage had been done to the cups. There was no report of any erroneous result generated or reported outside the laboratory. There was no report of any adverse event or patient injury requiring medical intervention or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9359925]
(b)(4). Customer did not return the sample cups.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-05914 |
| MDR Report Key | 2279721 |
| Report Source | 05,06 |
| Date Received | 2011-10-06 |
| Date of Report | 2011-09-06 |
| Date of Event | 2011-09-03 |
| Date Mfgr Received | 2011-09-06 |
| Date Added to Maude | 2012-02-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAMPLE CUPS, 0.5 ML |
| Generic Name | CONTAINER, SPECIMEN, NON-STERILE |
| Product Code | NNI |
| Date Received | 2011-10-06 |
| Model Number | NA |
| Catalog Number | 651412 |
| Lot Number | 1042839 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-06 |