MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-04-21 for SYNCHRON DRUG CALIBRATOR 1 469600 manufactured by Beckman Coulter, Inc..
[2606789]
Customer reported to beckman coulter, inc. (bec) that they were using drug calibrator 1 reagent and noticed a slow leak coming from the level 1 bottle near the top of the screw cap. Customer reported that they noticed the leak while filing the content into the sample cup of the unicel dxc 600i synchron access clinical system and realized there was not much solution in the bottle. Customer reported that erroneous results were not generated. There was no report of any adverse event or injury requiring medical intervention or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9821390]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9822775]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050010-2012-00013 |
| MDR Report Key | 2544142 |
| Report Source | 05,06 |
| Date Received | 2012-04-21 |
| Date of Report | 2012-03-27 |
| Date of Event | 2012-03-27 |
| Date Mfgr Received | 2012-03-27 |
| Device Manufacturer Date | 2011-10-07 |
| Date Added to Maude | 2012-09-13 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 2470 FARADAY AVENUE |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON DRUG CALIBRATOR 1 |
| Generic Name | CALIBRATORS, DRUG MIXTURE |
| Product Code | DKB |
| Date Received | 2012-04-21 |
| Model Number | NA |
| Catalog Number | 469600 |
| Lot Number | M103090 |
| Device Expiration Date | 2013-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BOULEVARD BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-21 |